Clinical trial · Interventional
A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors
A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced 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)
This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).
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 |
|---|---|---|---|
| Solid Tumor With p53 Wild Type Status | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGM097 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CGM097 - Dose escalation
- interventionNames
- Drug: CGM097
- type
- EXPERIMENTAL
- label
- CGM097 - Dose Expansion at MTD or RP2D
- interventionNames
- Drug: CGM097
Primary outcomes (1)
- measure
- Incidence of Dose Limiting Toxicities
- timeFrame
- From day 1 to day 28 of treatment
- description
- To characterize the maximum tolerated dose (MTD) and/or identify the recommended dose for expansion(RDE) of CGM097. Dose Limiting Toxicities will be listed and their incidence summarized by primary system organ class, worst grade based on CTCAE version 4.03 and type of Adverse Event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists * Tumor of the patient is p53wt * Evaluable disease as determined by RECIST 1.1 * WHO performance status 0-2 Exclusion criteria: * Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor * Patient with symptomatic or growing CNS metastatic lesions * Concurrent other malignancy * Clinically significant cardiac disease as defined in the protocol * Diagnosis of acute or chronic pancreatitis * Concomitant therapy that precludes enrollment, as defined in the protocol * Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDBauer S, Demetri GD, Halilovic E, Dummer R, Meille C, Tan DSW, Guerreiro N, Jullion A, Ferretti S, Jeay S, Van Bree L, Hourcade-Potelleret F, Wuerthner JU, Fabre C, Cassier PA. Pharmacokinetic-pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies. Br J Cancer. 2021 Aug;125(5):687-698. doi: 10.1038/s41416-021-01444-4. Epub 2021 Jun 17. PMID 34140638