BC3402 w/ Tremelimumab + Durvalumab (STRIDE) in Hepatocellular Carcinoma

NCT06608940 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: CASE5224
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and efficacy of an investigational (experimental) product called BC3402. This product is considered experimental because it is not approved by the U.S. Food and Drug Administration (FDA).

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

liver cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate(ORR) per RECIST v1.1

  The ORR rate and 95% CI will be calculated.

  From registration up to 2 years post end of treatment(EOT) or study closure

Secondary Outcomes (4)

• Duration of objective response

  From registration up to 2 years post end of treatment(EOT) or study closure

• Progression free survival(PFS), per RECIST v1.1

  From registration up to 2 years post end of treatment(EOT) or study closure

• Overall Survival(OS)

  From registration up to 2 years post end of treatment(EOT) or study closure

• Adverse events profile with AEs graded by the National Cancer Institute NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  From registration up to 2 years post end of treatment(EOT) or study closure

Study Arms (1)

BC3402 to tremelimumab plus durvalumab

EXPERIMENTAL

The study consists of two parts: a safety lead-in study part (Phase Ib) to confirm the tolerable dose (RP2D) of BC3402 in combination with T+D followed by an efficacy study part (Phase II) to evaluate preliminary efficacy of the study regimen in a single arm, two stage Minimax design. Note that participants who are treated at the RP2D in the Phase Ib study part will automatically be part of the Phase II study part.

Drug: BC3402; Drug: Durvalumab; Drug: Tremelimumab

Interventions

Tremelimumab DRUG

Tremelimumab, intravenous, 300 mg, 1 dose on Cycle 1 Day 1

BC3402 to tremelimumab plus durvalumab

BC3402 DRUG

BC3402, intravenous, 20 mg/kg, D1 and D15 of every 28 day cycle, continuous. BC3402 to be administered after completion of the infusion of durvalumab and/or tremelimumab on the days when BC3402 is to be administered with durvalumab and/or tremelimumab

BC3402 to tremelimumab plus durvalumab

Durvalumab DRUG

Durvalumab, intravenous, 1500 mg, every 4 weeks, continuous

BC3402 to tremelimumab plus durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Confirmed HCC based on histopathological findings from tumor tissue.
• Must not have received prior systemic therapy for advanced, non-resectable HCC.
• Must not be eligible for locoregional therapy for unresectable HCC. For participants who progressed after locoregional therapy for HCC, locoregional therapy(including Transarterial chemoembolization (TACE) or Transarterial radioembolization (TARE)) must have been completed ≥28 days prior to the baseline scan for the current study.
• Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
• Child-Pugh Score class A.
• The Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 at enrollment.
• o Note: HBV-positive participants must remain on antiviral therapy for the study duration and must continue therapy for 6 months after the last dose of study medication.
• At least 1 measurable lesion, not previously irradiated and/or embolized, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with CT or MRI, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
• Adequate organ and marrow function, as defined below. Criteria "a," "b," "c," and "f" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.
• Hemoglobin ≥9 g/dL
• Absolute neutrophil count ≥1000/μL
• Platelet count ≥75000/μL
• Total bilirubin (TBL) ≤2.0×ULN
• AST and ALT ≤5×ULN

You may not qualify if:

• Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
• Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Chair.
• Have received an investigational product or locoregional therapy within 28 days prior to the first dose of study drug(s).
• Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug(s). Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogeneic organ transplantation (eg, liver transplant).
• History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy).
• Ascites that require ongoing paracentesis, within 6 weeks prior to the first scheduled dose of study drug(s), to control symptoms.
• Main portal vein thrombosis present on imaging.
• Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months; adequate endoscopic therapy according to institutional standards is required for participants with history of esophageal variceal bleeding or assessed as high risk for esophageal variceal by the treating investigator.
• Participant currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn\'s disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves\' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). Participants without active disease in the last 5 years are excluded unless discussed with the Study Physician and considered appropriate for study participation. The following are exceptions to this criterion:
• Participants with vitiligo or alopecia

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

durvalumab; tremelimumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 23, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data included in the peer reviewed publication will be publicly available indefinitely. No raw data will be shared.
• Access Criteria: A peer-reviewed publication will be made available according to the publishing journal's specifications. Cleveland Clinic Foundation personnel will not share study data apart from that which has been published publicly.

Locations

US (1)