← Back to Search

PARP Inhibitor

Combination therapy dose expansion in ovarian cancer for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Tango Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has advanced or metastatic solid tumor with measurable disease based on RECIST v1.1.

Is ≥18 years of age at the time of signature of the main study ICF.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a new drug (TNG348) and its combination with another drug (olaparib) to treat certain types of cancer.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic solid tumors that can be measured, specifically those with BRCA1/2 mutations or HRD+ identified by a validated test. Participants must have good performance status and adequate organ/bone marrow function, and women must have a negative pregnancy test.Check my eligibility

What is being tested?

The study tests TNG348 alone and combined with Olaparib in patients with certain genetic mutations linked to cancer. It aims to assess safety, tolerability, proper dosing for future phases, how the body processes the drugs, and their effectiveness against cancer.See study design

What are the potential side effects?

Potential side effects include undesirable reactions that could lead to stopping treatment such as organ inflammation or dysfunction due to drug toxicity. Specific side effects are not listed but generally align with typical chemotherapy-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My advanced cancer can be measured by standard health scans.

Select...

I am 18 years old or older.

Select...

I am fully active or can carry out light work.

Select...

My solid tumor has a BRCA mutation or is HRD positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure anti-tumor activity using RECIST 1.1 (Phase 2 only)

To determine dosing for TNG348 alone and in combination (Phase 1 only)

Secondary outcome measures

Assess changes in levels of ubPCNA in response to TNG348 as single agent or in combination

Characterize olaparib concentrations when administered with TNG348

Characterize the plasma PK profile

+2 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Single agent dose expansion in ovarian cancerExperimental Treatment1 Intervention

Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 at the identified RP2D

Group II: Single agent dose expansion in breast cancerExperimental Treatment1 Intervention

Participants with BRCA 1/2 mutant breast cancer will receive TNG348 at the identified RP2D

Group III: Single Agent Dose EscalationExperimental Treatment1 Intervention

Participants with BRCA 1/2 mutant or HRD+ solid tumors will receive escalating doses of TNG348 to estimate the MTD

Group IV: Combination therapy dose expansion in pancreatic or prostate cancerExperimental Treatment2 Interventions

Participants with BRCA 1/2 mutant pancreatic or prostate cancer will receive TNG348 in combination with olaparib at the identified RP2D

Group V: Combination therapy dose expansion in ovarian cancerExperimental Treatment2 Interventions

Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 in combination with olaparib at the identified RP2D

Group VI: Combination therapy dose expansion in breast cancerExperimental Treatment2 Interventions

Participants with BRCA 1/2 mutant breast cancer will receive TNG348 in combination with olaparib at the identified RP2D

Group VII: Combination therapy dose expansion in HRD+ advanced or metastatic solid tumorsExperimental Treatment2 Interventions

Participants with HRD+ advanced or metastatic solid tumors will receive TNG348 in combination with olaparib at the identified RP2D

Group VIII: Combination Dose EscalationExperimental Treatment2 Interventions

Participants with BRCA 1/2 mutant or HRD+ solid tumors will receive escalating doses of TNG348 in combination with olaparib to estimate the MTD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tango Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

477 Total Patients Enrolled

Adam Crystal, MD, PHDStudy DirectorTango Therapeutics, Inc.

Tiffany Wang, MDStudy DirectorTango Therapeutics, Inc.

1 Previous Clinical Trials

126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment to this research study still available for participants?

"Yes, this clinical trial is currently accruing participants. Clinicaltrials.gov states that the initial post was made on December 8th 2023 and it has been revised as recently as 11 days ago."

Answered by AI

How many participants are taking part in this experiment?

"Indeed, the information accessible on clinicaltrials.gov demonstrates that this trial has been recruiting since December 8th 2023 and is in need of 140 participants at a single location."

Answered by AI

What are the prime goals of this clinical experiment?

"This 21 day clinical trial seeks to gauge the antitumor efficacy of TNG348 through RECIST 1.1 (Phase 2 only). Secondary objectives include measuring ubPCNA levels in both tumor tissue and blood, assessing single agent or combination anti-tumor activity via RECIST 1.1 per investigator assessment, and characterizing plasma PK profile with an eye towards calculating half-life for this particular medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

2023. "Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065059.

All > Prostate Cancer Tampa