Clinical Research Directory

Study of XB010 in Subjects With Solid Tumors

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors

Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors. * The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up). * During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria. 1. The dose escalation phase (Part 1) will consist of a single-dose period and a multiple-dose period (28 days as one cycle). Subjects in the dose escalation phase will receive a single dose of ANS014004 on Day 1 of the single-dose period to obtain the complete PK profile of a single dose. There will be a 7-day washout period between the single-dose period and the multiple-dose period at the same dose level. If no dose-limiting toxicity (DLT) occurs within the 7-day washout period, subjects will start multiple-dose treatment on Day 8 (28 days per cycle), receiving ANS014004 once daily (QD) or twice daily (BID). Dose escalation will first be conducted in the QD dosing cohort. When the dose escalates to Cohort 5, dose escalation in the BID dosing cohort with the same daily dose will be conducted in parallel. For each group with the same daily dose of QD or BID cohorts, subjects will be enrolled in the QD cohort first, followed by the BID cohort, and then dose escalation of the next daily dose of QD or BID cohorts will be conducted. Both the QD and BID dosing cohorts will include a single-dose period and a multiple-dose period. Based on the safety, PK and preliminary efficacy data of the QD and BID cohorts, the dosing frequency and dose of the backfill cohort will be selected. Subjects in the backfill cohort will directly enter the multiple-dose period. The RP2D will be determined based on the comprehensive assessment of safety, PK and preliminary efficacy data from the dose escalation phase. 2. In the dose expansion portion (Part 2), subjects will receive oral administration of ANS014004 at the RP2D dose QD or BID in each treatment cycle (28 days per cycle). The end-of-treatment (EOT) visit will be conducted within 7 days after the last dose or when the investigator decides to discontinue treatment. During the study period, the investigator and the sponsor may discuss and decide whether to stop exploring certain dose cohorts or to add exploration of other doses or dosing regimens based on the safety, PK and preliminary efficacy data obtained previously. All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first.

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

This is a Phase 1/2, open-label, dose escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of BC3195 in combination with pembroliaumab in participants with locally advanced or metastatic solid tumors.

A Study to Evaluate the Safety, Tolerability, PK, PD, and Preliminary Efficacy of CS01 in Patients With Locally Advanced or Metastatic Solid Tumors

This is an investigator-initiated clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CS01 in patients with locally advanced or metastatic solid tumors.

A Study of YL202 in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.

A Single-arm, Open-label, Multicenter, Phase Ib/II Clinical Trial of CVL237 Tablets in Combination With Serplulimab Injection for the Treatment of Advanced Solid Tumors With PTEN Loss or Low Expression

This is a single-arm, open-label, multicenter, Phase Ib/II clinical trial of CVL237 tablets in combination with serplulimab injection for the treatment of advanced solid tumors with PTEN loss or low expression

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors

This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 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 RO7502175 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.

Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation

The study is divided into 2 cohorts, Cohort 1 is patients with KRASG12C mutated non-small cell lung cancer who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitor; Cohort 2 is patients with KRASG12C mutated solid tumors (except non-small cell lung cancer) who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitor. Each cohort consists of two stages, and 10 subjects are planned to be enrolled in the first stage of each cohort. According to the preliminary efficacy and safety data, each party will discuss and decide whether to continue the second stage. Twenty to fifty subjects were planned to be enrolled in Stage II of each cohort. A total of 20-120 subjects were enrolled. Screened eligible subjects received GH21 in combination with D-1553 in 21-day cycles until the investigator considered the subject no longer benefiting, or the subject developed intolerable toxicity, or the subject withdrew consent, or the subject died, or was lost to follow-up, or received a new anticancer treatment, whichever came first.

A Study of YL202 in Selected Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Phase I, open-label, multi-center study

A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors

This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors

This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.

PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors

This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.

Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.

Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.

MPDL3280A-treatment-IST-UMCG

To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET, 89Zr-CD8 imaging and 18F-FB-IL2-PET - as complementary tools for selection of patients to be treated with MPDL3280A, within this treatment trial the investigators will assess safety, tolerability and anti-tumor activity of MPDL3280A in cancer patients, who have undergone investigational imaging.

A Study of TYK-00540 in Adult Patients With Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.

IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced/Metastatic Solid Tumors

The goal of this first-in-human, single-center, prospective, open-label, phase 1/2 trial is to evaluate the safety and efficacy of the interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) combined with or without immunochemotherapy in patients with locally advanced/metastatic solid tumors. The main questions aimed to answer are 1) to evaluate the safety and feasibility of MSC-IFNα in the treatment of locally advanced/metastatic solid tumors;2) to evaluate the anti-tumor effects of the MSC-IFNα combined with or without immunochemotherapy in the treatment of locally advanced/metastatic solid tumors; 3) to evaluate the pharmacokinetics/pharmacodynamics of MSC-IFNα and related immune effector cells.

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors

A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion