Clinical Research Directory

JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC

This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).

A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.

Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently ongoing.

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.

Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC

This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC

Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy. Methods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate \[ORR\], disease control rate \[DCR\], duration of response \[DOR\], progression-free survival \[PFS\], overall survival \[OS\]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.

JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

To evaluate the safety, tolerability, and preliminary efficacy of JS111 capsules in patients with locally advanced, metastatic, or recurrent NSCLC harboring EGFR mutations;to determine the recommended Phase II dose (RP2D).

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

SKB264 Plus Glecirasib in Advanced KRAS G12C-Mutant NSCLC: A Phase II Study

This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.

Comparative ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET/CT Imaging for Assessing TROP2 ADC Therapeutic Efficacy in EGFR-TKI Resistant Advanced NSCLC

The primary objective is to evaluate the correlation between ⁶⁸Ga-MY6349 PET/CT-derived metrics reflecting tumoral TROP2 expression activity (including SUVmax, SUVmean, MTV, TLG, etc.) and progression-free survival (PFS) assessed per RECIST v1.1. This study plans to enroll 100 EGFR-mutant patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance following first-line therapy with third-generation EGFR-TKIs. Screening assessments will be completed within 28 days after patients sign the informed consent form. Eligible subjects will undergo a baseline ⁶⁸Ga-MY6349 PET/CT scan prior to study drug administration, with imaging coverage from mid-thighs to the vertex of the skull. All subjects will receive a ¹⁸F-FDG PET/CT scan within 14 days after the ⁶⁸Ga-MY6349 PET/CT. For patients who have undergone ¹⁸F-FDG PET/CT within 14 days before the ⁶⁸Ga-MY6349 scan, the existing imaging data can be used for diagnostic performance evaluation, and repeat ¹⁸F-FDG PET/CT is not required. Subsequently, subjects will receive monotherapy with sacituzumab govitecan at a dose of 5 mg/kg via intravenous infusion (IV) on Day 1 of each cycle, administered every 2 weeks (Q2W). Treatment will continue until investigator-confirmed radiological disease progression, intolerable adverse toxicity, voluntary treatment discontinuation by the subject, or any other protocol-specified treatment discontinuation criterion, whichever occurs first. At 3 months after initiation of sacituzumab govitecan treatment, subjects will repeat the ⁶⁸Ga-MY6349 PET/CT scan (coverage: mid-thighs to vertex), followed by a ¹⁸F-FDG PET/CT examination within 14 days thereafter. Eligible subjects will receive regular tumor assessments in accordance with RECIST v1.1. Within 48 weeks after the first dose, imaging-based tumor assessments will be performed every 6 weeks (±7 days). At Week 12 (±1 week), paired ⁶⁸Ga-MY6349 and ¹⁸F-FDG PET/CT scans will be conducted without routine diagnostic CT. After Week 48, tumor assessments will be scheduled every 12 weeks (±7 days) until radiological disease progression, initiation of subsequent anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination by the sponsor, whichever comes first. Imaging assessments will follow the predetermined schedule regardless of dose delays or dose modifications. After the first documented complete response (CR) or partial response (PR), response confirmation imaging must be conducted no less than 4 weeks (28 days) later. For subjects discontinuing treatment for reasons other than radiological progression, death or loss to follow-up, if more than 4 weeks have passed since the last imaging evaluation, repeat imaging will be performed at the End-of-Treatment (EOT) visit. Subsequent imaging assessments will be conducted per schedule to the greatest extent feasible until radiological disease progression, initiation of new anti-tumor therapy, consent withdrawal, loss to follow-up, death, or sponsor-initiated study termination, whichever occurs earliest. All ⁶⁸Ga-MY6349 PET/CT images will be blindly and independently reviewed by two experienced nuclear medicine physicians who are not involved in this clinical trial (without access to any clinical data) to identify positive NSCLC lesions, as well as lesion location and count. In case of disagreement between the two independent readers regarding the presence of positive lesions, a blinded arbitration review by a senior nuclear medicine expert will be activated, and the arbitrator's reading results will serve as the final conclusion. All ¹⁸F-FDG PET/CT images will undergo single blinded independent review by one nuclear medicine physician. Upon completion of treatment, all subjects will complete safety follow-up regardless of whether they receive subsequent anti-tumor therapy. Telephone-based survival follow-up visits will be conducted every 3 months (±14 days) after the last dose of study treatment to collect survival status and information on subsequent anti-tumor treatments, until subject withdrawal, loss to follow-up, death, or study closure, whichever occurs first.

A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.

RGL-270 + ICI in Advanced NSCLC

This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1/PD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression

This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy

Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies

Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional/incisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+/- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional/incisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.