Clinical trial · Interventional
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors
NCT05985655CI-TRIAL-00121994ELUCIDATErecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma (HNSCC) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC) | — | UNRESOLVED | — |
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GTAEXS617 | Drug | — | UNRESOLVED |
| SoC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation Monotherapy
- description
- Participants will receive GTAEXS617 oral tablets in increasing doses.
- interventionNames
- Drug: GTAEXS617
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation Combination Therapy
- description
- Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
- interventionNames
- Drug: GTAEXS617
- Drug: SoC
- type
- EXPERIMENTAL
- label
- Phase 2: Dose Expansion Monotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months. * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC). * 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. * Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases. Key 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/moderate inhibitors and/or strong 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 treatment. * Received treatment with known substrates of organic anion transporting peptide 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. Note: Other protocol Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.