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Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II

ConditionsBiliary Tract Cancer (BTC)EGFR-positive Advanced Biliary Tract Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuiKai Li

About this trial

Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.

This open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.

EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).

Failed at least one line of standard systemic therapy.

Disqualifiers

Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.

EGFR expression negative by IHC.

Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.

Psychiatric or neurological disorders that compromise the ability to comply with study procedures.

Trial design

Design model

Single group

Treatments tested in this trial

  • Becotatug Vedotin

    Drug

    2.0mg/kg ，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

  • Pucotenlimab

    Drug

    200mg，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Becotatug Vedotin + PucotenlimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1.

Time frame
From start of treatment until disease progression, assessed up to 36 months.

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
From start of treatment to disease progression or death, assessed up to 36 months.
2

Overall Survival (OS)

Time from the first dose of study treatment to death from any cause.

Time frame
From start of treatment to death, assessed up to 36 months.
3

Disease Control Rate (DCR)

Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.

Time frame
From start of treatment until disease progression, assessed up to 36 months.
4

Duration of Response (DOR)

Time from the first documented objective response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
From first response to disease progression or death, assessed up to 24 months from response.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HuiKai Li

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: