Clinical trial · Interventional
Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
NCT01644968CI-TRIAL-00058519completedPhase 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 study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced 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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort 1 anti-OX40 | Drug | — | UNRESOLVED |
| Cohort 2 anti-OX40 | Drug | — | UNRESOLVED |
| Cohort 3 anti-OX40 | Drug | — | UNRESOLVED |
| KLH Day 1 | Biological | — | UNRESOLVED |
| KLH Day 29 | Biological | — | UNRESOLVED |
| Tetanus Day 1 | Biological | — | UNRESOLVED |
| Tetanus Day 29 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KLH + anti-OX40
- description
- Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
- interventionNames
- Drug: Cohort 1 anti-OX40
- Drug: Cohort 2 anti-OX40
- Drug: Cohort 3 anti-OX40
- Biological: Tetanus Day 29
- Biological: KLH Day 1
- type
- EXPERIMENTAL
- label
- Tetanus vaccine + anti-OX40
- description
- Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
- interventionNames
- Drug: Cohort 1 anti-OX40
- Drug: Cohort 2 anti-OX40
- Drug: Cohort 3 anti-OX40
- Biological: Tetanus Day 1
- Biological: KLH Day 29
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma. * ECOG performance status 0, 1, 2 * No active bleeding * No clinical coagulopathy * Anticipated lifespan greater than 12 weeks Exclusion Criteria: * Active residual toxicity from prior therapies * Active Infection * HIV positive * Hepatitis B or C positive * Pregnant or nursing women * Requirement for oral steroids * Brain metastases * Presence or history of autoimmune disease * Shellfish or tetanus allergy * Splenomegaly * Lymph nodes greater than 10 cm in maximal diameter * Uncontrolled angina or class II or IV heart failure
References
Publications (1)
- DERIVEDCurti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31. PMID 24177180