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

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Tango Therapeutics

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Breast Cancer
BRCA-Associated Breast Carcinoma
HRD Positive Advanced Ovarian Cancer
Pancreas Cancer
BRCA1 Mutation
BRCA-Mutated Ovarian Carcinoma
Ovarian Cancer
Prostate Cancer

Treatments

Drug: TNG348
Drug: Olaparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06065059
TNG348-C101

Details and patient eligibility

About

The goal of this interventional clinical trial is to learn about TNG348, a ubiquitin specific peptidase 1 (USP1) inhibitor, alone and in combination with olaparib in patients with BRCA 1/2 mutant or HRD+ solid tumors.

The main question[s] it aims to answer are:

  • to evaluate the safety and tolerability of single agent and combination therapy
  • to determine the recommended dose for Phase 2 of single agent and combination therapy
  • to determine the pharmacokinetics of TNG348 as a single agent and in combination therapy
  • to evaluate the initial antineoplastic activity as a single agent and in combination therapy

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

Full description

This is a first-in-human Phase 1/2, open-label, multi-center, dose-escalation and expansion study designed to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose(s) (RP2D) and evaluate the safety, tolerability, and preliminary antitumor activity of TNG348 single agent and in combination with olaparib in participants with BRCA1/2 mutant or other HRD+ advanced or metastatic solid tumors.

In Phase 1 (dose escalation), the single agent component will explore escalating oral doses of TNG348 administered alone and in combination with olaparib.

Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined from Phase 1 based on safety and tolerability demonstrated, along with the available PK data and studied during Phase 1, as applicable.

In the Phase 2 portion of the study, both single agent and combination therapy may be evaluated to assess an early signal of clinical benefit, as well as for confirmation of safety and tolerability.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Is ≥18 years of age at the time of signature of the main study ICF.
  • Has ECOG performance status of 0 or 1.
  • Has advanced or metastatic solid tumor with measurable disease based on RECIST v1.1.
  • All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test
  • Adequate organ and bone marrow function per local labs
  • Negative serum pregnancy test result at screening
  • Written informed consent must be obtained according to local guidelines

Exclusion criteria

  • Known allergies, hypersensitivity, or intolerance to TNG348, olaparib or its excipients
  • Uncontrolled intercurrent illness that will limit compliance with the study requirements
  • Currently participating in or has planned participation in a study of another investigational agent or device
  • Impairment of GI function or disease that may significantly alter the absorption of study drug
  • Active prior or concurrent malignancy.
  • Central nervous system metastases associated with progressive neurological symptoms
  • Participant with MDS
  • Clinically relevant cardiovascular disease
  • Participant with known active or chronic infection
  • A female patient who is pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

7 participants in 8 patient groups

Single Agent Dose Escalation
Experimental group
Description:
Participants with BRCA 1/2 mutant or HRD+ solid tumors will receive escalating doses of TNG348 to estimate the MTD
Treatment:
Drug: TNG348
Combination Dose Escalation
Experimental group
Description:
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:
Drug: Olaparib
Drug: TNG348
Single agent dose expansion in breast cancer
Experimental group
Description:
Participants with BRCA 1/2 mutant breast cancer will receive TNG348 at the identified RP2D
Treatment:
Drug: TNG348
Single agent dose expansion in ovarian cancer
Experimental group
Description:
Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 at the identified RP2D
Treatment:
Drug: TNG348
Combination therapy dose expansion in breast cancer
Experimental group
Description:
Participants with BRCA 1/2 mutant breast cancer will receive TNG348 in combination with olaparib at the identified RP2D
Treatment:
Drug: Olaparib
Drug: TNG348
Combination therapy dose expansion in ovarian cancer
Experimental group
Description:
Participants with BRCA 1/2 mutant ovarian cancer will receive TNG348 in combination with olaparib at the identified RP2D
Treatment:
Drug: Olaparib
Drug: TNG348
Combination therapy dose expansion in pancreatic or prostate cancer
Experimental group
Description:
Participants with BRCA 1/2 mutant pancreatic or prostate cancer will receive TNG348 in combination with olaparib at the identified RP2D
Treatment:
Drug: Olaparib
Drug: TNG348
Combination therapy dose expansion in HRD+ advanced or metastatic solid tumors
Experimental group
Description:
Participants with HRD+ advanced or metastatic solid tumors will receive TNG348 in combination with olaparib at the identified RP2D
Treatment:
Drug: Olaparib
Drug: TNG348

Trial contacts and locations

7

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Central trial contact

Tiffany Wang, MD

Data sourced from clinicaltrials.gov

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