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

Last updated: April 28, 2024
Sponsor: Antengene Therapeutics Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Pembrolizumab

ATG-037

Keytruda(Pembrolizumab, MK-3475)

Clinical Study ID

NCT05205109
ATG-037-001
KEYNOTE-E73
3475-E73
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent prior to any study-specificprocedures, 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 orrefractory to standard therapies.
  4. There is at least one measurable lesion according to Response Evaluation Criteria inSolid 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 orSD>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 endof treatment, should not be breastfeeding.
  9. Male subjects should be willing to use barrier contraception, ie condoms, for theduration of the study and 180 days after the final dose of study treatment.
  10. Subjects should have adequate organ function.

Exclusion

Exclusion Criteria:

  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 priorline therapy to disease progression lasting no more than 90 days).
  4. Prior therapy with any chemotherapy, immunotherapy, anticancer agents orinvestigational products from a previous clinical study within 28 days of the firstdose of study treatment or within a period during which the investigational product orsystemic anticancer treatment has not been cleared from the body.
  5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with alimited field of radiation for palliation within 14 days of the first dose of studytreatment. Subject must have recovered from all radiation related toxicity, notrequiring corticosteroids.
  6. Prior major surgery (excluding placement of vascular access) within 28 days of thefirst dose of study treatment or minor surgical procedures ≤7 days.
  7. Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Anyunresolved toxicities from prior therapy greater than Common Terminology Criteria forAdverse 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 systemicdiseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renaldisease, active bleeding diseases, allogeneic stem cell transplantation, or any solidorgan transplant, etc.

Study Design

Total Participants: 98
Treatment Group(s): 4
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
June 07, 2022
Estimated Completion Date:
February 28, 2028

Study Description

This is a Phase I, 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.

Number of subjects :

  1. 39-51 subjects for Dose escalation phase part 1

  2. Maximum of 18 subjects or Dose escalation phase part 2

  3. 24-34 subjects per Dose expansion cohort

Connect with a study center

  • Calvary Mater Newcastle

    Sydney, New South Wales 2298
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • One Clinical Research Pty Ltd

    Mount Pleasant, Western Australia WA6153
    Australia

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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