A Phase 1 interventional study of DAT-2645 tablet and DAT-2645 tablet in Solid Cancers, BRCA Mutation and HRD Cancer, sponsored by Danatlas Pharmaceuticals Co., Ltd. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Danatlas Pharmaceuticals Co., Ltd · Phase 1, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 112 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Danatlas Pharmaceuticals Co., Ltd is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Monotherapy, dose escalation to definite MTD or RDE.
Drug: DAT-2645 tablet
Dose optimizing by 2 dose level after dose escalation to definite RP2D
Drug: DAT-2645 tablet
To evaluate safety and efficacy of DAT-2645 tablet in solid tumor under RP2D dosage
Drug: DAT-2645 tablet
The patient will be randomized into 2 groups and take DAT-2645 tablet daily. dosage is optimal dose-1 or optimal dose-2, 21day/ Cycle. The subject of this part is to optimize dosage and definite RP2D.
The study set 6 dose level cohorts in dose escalation part.On C0D1, patient take DAT-2645 one time (Single use), The dosage is same as his enrolled cohort dose level. if no DLT, 7 days later(C1D1), patients will continue taking DAT-2645 tablet daily, dasage is same as before, 21days/cycle.
Part 1, Dose esclalation study:To characterize the safety and tolerability of DAT-2645 monotherapy by evaluating the number of participants with dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0
The incidence of dose limiting toxicites Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time frame: 6 months
Part 2, Dose expansion study: To evaluate preliminary preliminary anti-tumor activity of DAT-2645 tablet monotherapy in participants by measuring tumor Overall Response Rate using RECIST criteria v1.1
Tumor response: Overall Response Rate(ORR) assessed by the investigators based on RECIST v1.1 criteria
Time frame: Approximately 2 years
RP2D
Recommended Phase 2 dose, will be definite by safety mornitoring committe(SMC).
Time frame: Approximately 6 months
ORR
Objective Response Rate (ORR) was calculated the rate of response of complete response (CR) or partial response (PR).
Time frame: Average of 6 months
DCR
Defined as not meeting the criteria for progression and PR(partial response)
Time frame: Average of 6 months
DoR
DoR(duration of response) per RECIST v1.1(Response Evaluation Criteria in Solid Tumours). Measured in CT/MRI image from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.
Time frame: Approximately 1 years
PFS
Progression- free survival (PFS) by RECIST V1.1 criteria- from the beginning of treatment to the progression of disease or death.
Time frame: Approximately 2 years
OS
Overall Survival (OS) was defined as the time interval between a patient randomized and death from any cause or the end of the last follow-up date.
Time frame: Approximately 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
PK parameters of DAT-2645 and metabolite over time at Cycle 0 Day 1 and at steady state (Cycle 1 Day 21) to model Area Under the the Plasma Concentration Versus Time Curve (AUC) with trough levels at the beginning of every Cycle thereafter
Time frame: Approximately 1 years
Changes in lysate poly (ADP-ribose) (PAR) level
As a PD parameter, detect the PAR level in peripheral blood mononuclear cell (PBMC) before and after administration of DAT-2645. Explore the correlation between DAT-2645 exposure and PD parameter, safety events.
Time frame: 6 months
Correlations between patients' baseline characteristics and effecacy
Correlations between patients' baseline characteristics (e.g., DDR deficiency type, tumor type) and objective response rate (ORR), to explore the best biomarker for tumor selection.
Time frame: Approximately 2 years
Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645 in Part 1 and Part 2
PK parameters of DAT-2645 and metabolite over time at Cycle 0 Day 1 and at steady state (Cycle 1 Day 21) to model time to maximum concentration (Tmax) with trough levels at the beginning of every Cycle thereafter
Time frame: Approximately 1 years
Maximal Plasma Concentration (Cmax) of DAT-2645 in Part 1 and Part 2
PK parameters ofDAT-2645 and metabolite over time at Cycle 0 Day 1-Cycle 0 Day 6 and at steady state (Cycle 1 Day 21) to model maximum concentration (Cmax) with trough levels at the beginning of every Cycle thereafter
Time frame: Approximately 1 years
Plan to share: Yes — only IPD used in the results publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: Danatlas will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please contact with us by information@danatlas.com.
Access criteria: When a request has been approved Danatlas will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Please contact with sponsor by email information@danatlas.com
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Start is estimated for Nov 2024; primary completion for Nov 2026, 24 months later.
Of 306 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's planned 24 months is below that.
Counting every sponsor, half of 645 studies reached it within 45 months; a quarter within 25 and three quarters within 66.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Danatlas Pharmaceuticals Co., Ltd