Clinical trial · Interventional
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.
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 |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Adenocarcinoma | Castration-Resistant Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCW702 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1a: Dose Escalation QOD
- description
- CCW702 administered subcutaneously QOD, dose escalating cohorts.
- interventionNames
- Drug: CCW702
- type
- EXPERIMENTAL
- label
- Part 1b: Dose Escalation Q7D
- description
- CCW702 administered subcutaneously Q7D, dose escalating cohorts.
- interventionNames
- Drug: CCW702
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- CCW702 administered subcutaneously Q7D at RP2D.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 18 years of age at time of informed consent * For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria * Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression * Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide). * Eastern Cooperative Oncology Group performance status of 0-1 * Adequate liver function * Adequate hematopoietic function * Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L) * Patient has a life expectancy of greater than 12 weeks Exclusion Criteria: * Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology * Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD) * Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment * Patients with peripheral neuropathy CTCAE Grade \>/= 2 * Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients * Patients with untreated or imminent spinal cord compression
References
Publications (2)
- BACKGROUNDKim CH, Axup JY, Lawson BR, Yun H, Tardif V, Choi SH, Zhou Q, Dubrovska A, Biroc SL, Marsden R, Pinstaff J, Smider VV, Schultz PG. Bispecific small molecule-antibody conjugate targeting prostate cancer. Proc Natl Acad Sci U S A. 2013 Oct 29;110(44):17796-801. doi: 10.1073/pnas.1316026110. Epub 2013 Oct 14. PMID 24127589
- DERIVEDLee SC, Ma JSY, Kim MS, Laborda E, Choi SH, Hampton EN, Yun H, Nunez V, Muldong MT, Wu CN, Ma W, Kulidjian AA, Kane CJ, Klyushnichenko V, Woods AK, Joseph SB, Petrassi M, Wisler J, Li J, Jamieson CAM, Schultz PG, Kim CH, Young TS. A PSMA-targeted bispecific antibody for prostate cancer driven by a small-molecule targeting ligand. Sci Adv. 2021 Aug 11;7(33):eabi8193. doi: 10.1126/sciadv.abi8193. Print 2021 Aug. PMID 34380625