Clinical trial · Interventional
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
NCT05712889CI-TRIAL-00082578completedPhase 1ClinicalTrials.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)
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VIP236 (Q2W) | Drug | — | UNRESOLVED |
| VIP236 (Q3W) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation of VIP236 (Q3W)
- description
- Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle
- interventionNames
- Drug: VIP236 (Q3W)
- type
- EXPERIMENTAL
- label
- Dose Escalation of VIP236 (Q2W)
- description
- Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 and D15 of each 28-day cycle.
- interventionNames
- Drug: VIP236 (Q2W)
Primary outcomes (2)
- measure
- Incidence of DLT (Dose limit toxicity) of VIP236
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients aged \>/=18 years, able to provide informed consent and willing to comply with all study procedures. * Histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. Refer to NCCN guidelines of each respective histology for guidance. Starting with Amendment 3, this study will focus enrollment on the following cancers: Biliary tract cancers Breast cancer Cervical cancer Endometrial carcinoma Gastric cancer/gastroesophageal junction adenocarcinoma Nonsmall cell lung cancer Ovarian cancer/fallopian tube cancer/primary peritoneal cancer Pancreatic adenocarcinoma Small cell lung cancer Urothelial cancer * Adequate bone marrow, liver, and renal functions. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: * Subjects who have new or progressive brain or meningeal or spinal metastases. * Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose. * Major surgery or significant trauma within 4 weeks before the first dose of study drug. * Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.
References
Publications (0)
Data not yet available
No reference posted for this study.