A Study of CBP-1018 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title: An Open-Label, Non-randomized, Multi-center Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1018 in Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Both parts include screening period, treatment period, end of treatment (EOT)/withdrawal, safety follow-up (SFU) and long-term-follow-up (LTFU). CBP-1018 will be administrated on eligible subjects until disease progression, unacceptable toxicity, withdrawal of consent or Sponsor's decision to stop the study, etc.

Clinical Trial Description

Part A (Dose Escalation) is to evaluate the safety, tolerability, PK and preliminary efficacy of CBP-1018 and determine the MTD and RP2D of CBP-1018 administrated iv Q2W (4 weeks/cycle), utilizing accelerated titration at lower doses (0.03 mg/kg and 0.06 mg/kg) and an i3+3 design at following doses (0.08 mg/kg,0.10 mg/kg,0.12 mg/kg and 0.14mg/kg, etc.), respectively. The DLT evaluation period will be 28 days from the first dose of CBP-1018. Up to 2 subjects will be allowed under DLT evaluation period at the same time. The interval between the first treatment of CBP-1018 to the 2 subjects under DLT evaluation period at the same time, is at least 1 week. Safety monitoring committee (SMC), comprised of Investigators and sponsor's medical personnel, etc., will be responsible for safety monitoring, dose escalation safety review and justification, MTD/RP2D determination, and other critical study decisions. A higher dose level may be added on the decision of SMC, if MTD is not observed at 0.14mg/kg. Intermediate dose levels among planned dose levels may also be added by SMC for further exploration. RP2D may be the same dose level as MTD or lower than it. Up to 10 additional subjects will be enrolled in one or more dose levels that have been shown to be safe and tolerable to better estimate the RP2D and better characterize the safety, efficacy, and pharmacodynamics for CBP-1018. Different schedules (QW or Q3W, for example) may be explored in Part A, according to emerging clinical and PK data, either.

Part B (Dose Expansion) is to further evaluate the efficacy and safety profile of CBP-1018 in 4 tumor-specific cohorts, with a Simon's two-stage design in each cohort:

• Cohort 1 (Metastatic castration resistant prostate cancer, mCRPC): subjects with mCRPC have documented failure of prior standard of care (SoC), such as new hormone therapy (Enzalutamide, apalutamide, etc.), Abiraterone and chemotherapy (Docetaxel, Cabazitaxel, etc.).

• Cohort 2 (Advanced renal cell cancer, RCC): subjects with advanced RCC have documented failure of prior SoC, such as immunotherapy (PD-1/L1 antibody) combined with anti-angiogenic therapy, targeted therapy (VEGF or mTOR inhibitor, etc.).

• Cohort 3 (Advanced lung squamous cell cancer, LSCC): subjects with advanced LSCC have documented failure of prior SoC, such as immunotherapy (PD-1/L1 antibody) combined with chemotherapy (platinum-based regimen)，chemotherapy (Taxane, Gemcitabine, etc.).

• Cohort 4 (Other advanced solid tumors): subjects with other advanced solid tumors have documented failure of prior SoC. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

• NCT number: NCT04928612
• Study type: Interventional
• Source: Coherent Biopharma (Suzhou) Co., Ltd.
• Contact: Jiangang Yu, Ph D
• Phone: 0512-85550899
• Email: jiangang.yu@coherentbio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: November 4, 2021
• Completion date: October 2024