ELUCIDATE: Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the following advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial carcinoma.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GTAEXS617 GTAEXS617 tablet for oral administration |
Drug: GTAEXS617
GTAEXS617 tablets daily
|
Outcome Measures
Primary Outcome Measures
- Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy [Through patient study completion, an average of 6 months]
Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.
- Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy [Through patient study completion, an average of 6 months]
Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment.
- Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy [Through study completion for all patients in Module 1 Part A. Estimated 18 months.]
The RP2D will not exceed the maximum tolerated dose (MTD) if established.
- Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens [Through patient study completion, an average of 6 months]
Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.
- Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens [Through patient study completion, an average of 6 months]
Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment
Secondary Outcome Measures
- Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax) [Through patient study completion, an average of 6 months]
Maximum Plasma Concentration (Cmax) when GTAEXS617 administered as monotherapy
- Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax) [Through patient study completion, an average of 6 months]
Time Maximum Plasma Concentration (Tmax) when GTAEXS617 administered as monotherapy
- Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) [Through patient study completion, an average of 6 months]
Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) when GTAEXS617 administered as monotherapy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ECOG performance status 0-1
-
Life expectancy >3 months
-
One the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma
-
Patients must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments
-
Adequate hematological, liver, and renal function
-
Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases
Exclusion Criteria:
-
Active and clinically significant (CS) infection
-
Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617
-
Symptomatic central nervous system (CNS) malignancy or metastases
-
Concurrent active or previous malignancy
-
Prior organ or allogeneic stem-cell transplantation
-
Moderate or severe cardiovascular disease
-
Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment
-
Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment
-
Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study
-
Received treatment with known substrates of organic anion transporting peptide 1B3 (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study treatment
-
Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
-
Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Universitaires Saint-Luc | Brussels | Belgium |
Sponsors and Collaborators
- Exscientia AI Limited
- GT Apeiron LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GTAEXS617-001