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RecruitingLast updated: 3 April 2024

This study is assessing the effectiveness of a new targeted therapy (called ATG-037) when it is given alone, or in combination with immunotherapy, in people with locally advanced or metastatic solid cancersA Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This study aims to determine the recommended dose level and assess the effectiveness of a new targeted therapy (called ATG-037) when given alone, and in combination with immunotherapy (pembrolizumab).

ATG-037 Monotherapy: Part I: ATG-037 will be administered orally once a day on D-2, then multiple doses of ATG-037 will be administered orally twice a day every day from C1D1. A treatment cycle will be 21-days. Part II: ATG-037 will be administered orally twice a day every day from C1-D1.

ATG-037 + Pembrolizumab: Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with pembrolizumab 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years). Part II: Pembrolizumab will be administered from C1. 

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Antengene Therapeutics Limited

Scientific Title

A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
  2. Aged at least 18 years as of the date of consent.
  3. Histological or cytological confirmation of a solid tumor that has relapsed from or refractory to standard therapies.
  4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  5. Estimated life expectancy of a minimum of 12 weeks.
  6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD>6 months).
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
  8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.
  9. Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.
  10. Subjects should have adequate organ function.

Exclusion

  1. Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.
  2. Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.
  3. Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).
  4. Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.
  5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids.
  6. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
  7. Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.
  8. Subjects receiving unstable or increasing doses of corticosteroids.
  9. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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