Clinical trial · Interventional
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose
- 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)
Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab
Conditions
Conditions (2)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KEYTRUDA® (pembrolizumab) | Drug | Pembrolizumab | ALIAS |
| Q901 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose escalation (Q901)
- interventionNames
- Drug: Q901
- type
- EXPERIMENTAL
- label
- Q901 Single-Agent Expansion Cohorts
- interventionNames
- Drug: Q901
- type
- EXPERIMENTAL
- label
- Q901 + KEYTRUDA® (pembrolizumab) Cohorts
- interventionNames
- Drug: Q901
- Drug: KEYTRUDA® (pembrolizumab)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit * Measurable disease per RECIST v 1.1 * ECOG performance status 0,1 or 2 * Life expectancy of at least 3 months * Age ≥ 18 years * Signed, written IRB-approved informed consent form Exclusion Criteria: * New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months * Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males) * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Active, poorly controlled autoimmune or inflammatory diseases
References
Publications (0)
Data not yet available