Clinical trial · Interventional
Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors
NCT04665206CI-TRIAL-00107087recruitingPhase 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)
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab & Ipilimumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
| Osimertinib | Drug | Osimertinib | ALIAS |
| Pemetrexed/Carboplatin | Drug | — | UNRESOLVED |
| VT3989 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- VT3989 Dose Escalation [Not Recruiting]
- description
- VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase
- interventionNames
- Drug: VT3989
- type
- EXPERIMENTAL
- label
- Dose Expansion [Not Recruiting]
- description
- VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma.
- interventionNames
- Drug: VT3989
- type
- EXPERIMENTAL
- label
- Combination [Recruiting]
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy. * Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib. * Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy. * Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma. * ECOG: 0-1. * Adequate organ functions, including the liver, kidneys, and hematopoietic system. Exclusion Criteria: * Active brain metastases or primary CNS (central nervous system) tumors. * History of leptomeningeal metastases * Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Known HIV positive or active Hepatitis B or Hepatitis C * Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents. * Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula). * Additional active malignancy that may confound the assessment of the study endpoints * Women who are pregnant or breastfeeding * Prior treatment with TEAD inhibitor.
References
Publications (1)
- DERIVEDYap TA, Kwiatkowski DJ, Dagogo-Jack I, Offin M, Zauderer MG, Kratzke R, Desai J, Body A, Millward M, Tolcher AW, Raghav KPS, Thurston A, Post L, Dorr FA, Tang TT, Li Y, Sharma N, Kindler HL. YAP/TEAD inhibitor VT3989 in solid tumors: a phase 1/2 trial. Nat Med. 2025 Dec;31(12):4281-4290. doi: 10.1038/s41591-025-04029-3. Epub 2025 Oct 19. PMID 41111090