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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

PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.

Aged at least 18 years as of the date of consent.

Histological or cytological confirmation of a solid tumor that has relapsed from or refractory to standard therapies.

There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Estimated life expectancy of a minimum of 12 weeks.

Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD>6 months).

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.

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.

Subjects should have adequate organ function.

Exclusion criteria

Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.

Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.

Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).

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.

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.

Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.

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.

Subjects receiving unstable or increasing doses of corticosteroids.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-06-07

Primary completion: 2027-08-30

Study completion finish: 2028-02-28

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05205109

Intervention or treatment

DRUG: ATG-037

DRUG: KEYTRUDA ®( Pembrolizumab)

Conditions

• Locally Advanced or Metastatic Solid Tumors

Image related to Locally Advanced or Metastatic Solid Tumors

Condition: Locally Advanced or Metastatic Solid Tumors
DRUG: ATG-037 and other drugs
Benowa, Queensland, Australia and more
Sponsor: Antengene Therapeutics Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Pindara Private Hospital

Research sites nearby

Select from list below to view details:

Pindara Private Hospital
Benowa, Queensland, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Calvary Mater Newcastle
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ATG-037+Keytruda(Pembrolizumab, MK-3475) Part I: Dose Escalation Phase of ATG-037 Monotherapy PartII: Dose Escalation Phase and Dose Expansion Phase of ATG-037 in Upfront Combination with Keytruda(Pembrolizumab, MK-3475)	DRUG: ATG-037 Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days. Part II: ATG-037 will be administered orally BID for every day from C1D1.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of adverse events and server adverse events	Will be graded according to the NCI-CTCAE Grading Scale version 5.0.	One year after last patient first dose
DLT	Number of Participants with Dose Limiting Toxicity	Up to 21 Days
MTD	Maximum tolerated dose of ATG-037	Up to 21 Days
RP2D	Recommended phase 2 dose of ATG-037	Up to 21 Days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Plasma concentration of ATG-037 and derived PK parameters	To characterize the PK/PDx of ATG-037	One year after last patient first dose
Inhibition of CD73 enzymatic activity in plasma	To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab	One year after last patient first dose
ORR as per RECIST v1.1 and DOR, DCR, PFS, OS evaluated by the investigators	To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab	One year after last patient first dose

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: 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