Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

NCT ID: NCT07159217

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2028-05-31

Brief Summary

This trial is a single-arm exploratory phase II clinical study initiated by the investigator.

Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.

Conditions

Biliary Tract Cancer; Disitamab Vedotin; Lenvatinib; Immune Checkpoint Inhibitors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor

Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)

Group Type: EXPERIMENTAL

Disitamab Vedotin

Intervention Type: DRUG

2.0 mg/kg administered intravenously every three weeks

Lenvatinib

Intervention Type: DRUG

≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

Pembrolizumab

Intervention Type: DRUG

200 mg intravenously every three weeks

Toripalimab

Intervention Type: DRUG

240 mg intravenously every three weeks

Camrelizumab

Intervention Type: DRUG

200 mg intravenously every three weeks

Interventions

Disitamab Vedotin

2.0 mg/kg administered intravenously every three weeks

Intervention Type: DRUG

Lenvatinib

≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

Intervention Type: DRUG

Pembrolizumab

200 mg intravenously every three weeks

Intervention Type: DRUG

Toripalimab

240 mg intravenously every three weeks

Intervention Type: DRUG

Camrelizumab

200 mg intravenously every three weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.

2. Age ≥ 18 years and any gender.

3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

4. At least one measurable lesion (according to RECIST 1.1).

5. ECOG performance status score of 0-1.

6. Child-Pugh score ≤ 7 .

7. HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2/CEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.

8. No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.

9. Expected survival > 12 weeks.

10. Adequate hematological and major organ function.

Exclusion Criteria

1. Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.

2. Pregnant women (positive pregnancy test before medication) or lactating women.

3. Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.

4. History of other active malignancies within 5 years prior to screening.

5. Presence of central nervous system metastasis and/or leptomeningeal metastasis.

6. Unhealed severe wounds, active ulcers, or untreated fractures.

7. Administration of live vaccines within 30 days prior to randomization.

8. Active autoimmune disease or history of autoimmune disease.

9. Presence of clinically significant gastrointestinal disorders.

10. Presence of clinically significant cardiovascular or cerebrovascular diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

Beijing, , China

Countries

China

Central Contacts

Shuofeng Li

Role: CONTACT

shuofengli@yeah.net

+86-10-69156042

Facility Contacts

Haitao Zhao

Role: primary

zhaoht@pumch.cn

+86-10-69152830

References

Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M. Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. Drug Deliv. 2022 Dec;29(1):1335-1344. doi: 10.1080/10717544.2022.2069883.

Reference Type: BACKGROUND

PMID: 35506447 (View on PubMed)

Other Identifiers

K8721

Identifier Type: -

Identifier Source: org_study_id