Clinical trial · Interventional
Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
- 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)
Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-777607 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: BMS-777607
Primary outcomes (2)
- measure
- Safety and efficacy assessment including vitals signs, physical assessments, and blood tests
- timeFrame
- will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months
- measure
- Tumor assessments
- timeFrame
- will be conducted every 6 weeks. All assessments will continue for at least 24 months
Secondary outcomes (4)
- measure
- Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part A: * Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known Part B: * Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on standard therapy, or for whom standard therapy is not known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will be treated. Subjects with PRCC (up to 18) will be enrolled as feasible * Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must be provided * Subjects with HRPrC must have either measurable disease or rising PSA levels (≥3 consecutive rising levels with at least 1 week interval and with PSA level ≥5 mg/ml). All other subjects must have measurable disease as assessed by CT or MRI Exclusion Criteria: * Know brain metastases * Uncontrolled or significant cardiovascular disease * Retinal atrophy
References
Publications (0)
Data not yet available