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A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway

A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DNA Damage Repair Pathway

NCT06614751•Danatlas Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the DNA damage repair (DDR) pathway.

Detailed Description

This the the FIH trial of PARG inhibitor DAT-2645.This study will include Part 1 dose escalation study and Part 2 dose expansion study. Eligible patients will be enrolled into Part 1 and Part 2. In Part 1, 6 dose cohorts will be set and definte MTD/RDE. In Part 2, Dose optimization will be conducted firstly to definite RP2D. dose expansion will be conducted in another 2 cohorts to evaluate the efficacy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent prior to initiation of any procedures in this study.
•At least 18 years of age (inclusive).
•Evidence of an DDR deficiency status in tumor tissue determined by validated testing method.
•Patients with advanced or metastatic solid tumor who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain/unwilling to receive standard therapy. Regardless of PARP inhibitors were used or not in previous treatment.
•At least one measurable lesion by RECIST v1.1 criteria.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0\~2.
•Life expectancy at least 3 months.
•Adequate hematologic and non-hematologic function during the screening.
•Women of childbearing potential must have a negative result of serum pregnancy test at screening.
•Women of childbearing potential or male patients whose spouse have childbearing potential must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug.

Exclusion Criteria

•Patients who received systemic chemotherapy, small-molecule targeted drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
•Patients who received biological anti-tumor drugs (including immunotherapy, target therapy, antibody-drug conjugate \[ADC\]) within 4 weeks prior to the first dose of the study drug.
•Patients who have undergone major surgery within 4 weeks prior to the first dose of study drug.
•Patients who have received radiotherapy within 4 weeks prior to the first dose of study drug (palliative radiotherapy for non-target lesions could be acceptable if it was performed before 14 days prior to the first dose of study drug).
•Any previous treatment with a PARG inhibitor.
•Patients with active CNS metastases (patients with asymptomatic CNS metastases which are imaging stable and not require steroid treatment within 28 days prior to the first dose of study drug, and previous treated breast cancer brain metastasis, can only be enrolled in the Part 2 study).
•Patients who have second primary malignant tumors within the past 3 years prior to screening, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.
•Patients with clinically significant cardiovascular or cerebrovascular diseases.
•Active uncontrolled infections requiring intravenous antibiotics or hospitalization.
•Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of DAT-2645 and no history of bowel obstruction within 6 months prior to enrollment.
+8 more criteria

Locations (2)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, China

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijjing, Beijing Municipality, China

Key Dates

Start Date

November 1, 2024

Primary Completion Date

November 1, 2026

Completion Date

June 1, 2027

Last Updated

September 27, 2024

Enrollment

112

ESTIMATED participants

Conditions

Solid CancersBRCA MutationHRD CancerBreast CancerProstate CancerColorectal CancerPancreatic CancerEndometrial CancerGastric CancerAdvanced CancerMetastatic Solid Tumors

Interventions

DAT-2645 tablet

DRUG

DAT-2645 tablet

DRUG

Contacts

Danatlas Pharmaceuticals Co.

CONTACT

+86-18911453323 information@danatlas.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

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