Clinical trial · Interventional
First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer
NCT05159440CI-TRIAL-00081810active not recruitingPhase 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)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer
Conditions
Conditions (4)
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TORL-2-307-MAB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Dose Finding - Part 1
- description
- TORL-2-307-MAB
- interventionNames
- Drug: TORL-2-307-MAB
- type
- EXPERIMENTAL
- label
- Expansion as Monotherapy - Part 2
- description
- TORL-2-307-MAB
- interventionNames
- Drug: TORL-2-307-MAB
Primary outcomes (3)
- measure
- Incidence and severity of adverse events and serious adverse events
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced solid tumor * Measurable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-MAB * Progressive or symptomatic brain metastases * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * History of significant cardiac disease * History of myelodysplastic syndrome (MDS) or AML * History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded * If female, is pregnant or breastfeeding
References
Publications (1)
- DERIVEDO'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353. PMID 37788341