D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer

NCT06622057 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Inno-GO-07
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Conditions

Biliary Tract Cancer (BTC)

Keywords

BTC; cholangiocarcinoma; Biliary Tract Cancer; third-line

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  To assess the over survival (OS) of 2 doses of D07001-softgel capsules + capecitabine compared with placebo + capecitabine

  From date of randomization until the date of death, assessed up to 2 years

Secondary Outcomes (4)

• progression-free survival (PFS)

  From randomization to death or progression disease, assessed up to 2 years

• 6-month survival rate

  Assessed as the time at 6 month timepoint from randomization

• overall response rate (ORR)

  From treatment starting until end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).

• Quality of life (QOL) will be assessed using the EORTC questionnaires

  Assessed as the time from randomization to end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).

Study Arms (3)

D07001-Softgel Capsules 60 mg + Capecitabine

EXPERIMENTAL

* D07001-softgel capsules, 60 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.

Drug: D07001-Softgel Capsules; Combination Product: Capecitabine

D07001-Softgel Capsules 100 mg + Capecitabine

EXPERIMENTAL

* D07001-softgel capsules, 100 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.

Drug: D07001-Softgel Capsules; Combination Product: Capecitabine

Placebo + Capecitabine

PLACEBO COMPARATOR

* Placebo, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner.

Drug: Placebo; Combination Product: Capecitabine

Interventions

D07001-Softgel Capsules DRUG

D07001-softgel capsule is an oral gemcitabine.

D07001-Softgel Capsules 100 mg + Capecitabine; D07001-Softgel Capsules 60 mg + Capecitabine

Placebo DRUG

Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)

Placebo + Capecitabine

Capecitabine COMBINATION_PRODUCT

Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.

D07001-Softgel Capsules 100 mg + Capecitabine; D07001-Softgel Capsules 60 mg + Capecitabine; Placebo + Capecitabine

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements
• Aged at least 18 years.
• Has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC.
• Has measurable disease as assessed by RECIST v1.1.
• Must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on or irinotecan + fluorouracil chemotherapy.
• Participants with tumors expressing the following biomarkers can be enrolled if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors aberrations, microsatellite instability biomarker/deficient DNA mismatch repair, or isocitrate dehydrogenase mutations.
• ECOG PS of 0-2.
• Life expectancy is ≥12 weeks.
• Has adequate bone marrow function, demonstrated by: (a) ANC ≥1500 cell/mm3; (b) Platelet count ≥85,000 cells/mm3; (c) Hemoglobin ≥9 g/dL.
• Has adequate liver function, demonstrated by: (a) AST and ALT ≤2.5 × ULN, or ≤5.0 × ULN in the case of liver lesions; (b) Total bilirubin ≤1.5 × ULN; (c) Albumin ≥3.0 g/dL; (d) INR \<1.5.
• Has adequate renal function, demonstrated by CCR ≥ 45 mL/min or eGFR ≥ 45 mL/min/1.73 m2
• No clinically significant abnormalities in coagulation results.
• Participant is eligible to participate if not pregnant (as demonstrated by serum pregnancy testing at screening), not breastfeeding, and at least 1 of the following conditions applies:
• Not of childbearing potential (CBP).
• A participant of CBP who is sexually active with a partner who could impregnate them agrees to use a highly effective form of contraception during the study and for at least 30 days after the end of study intervention.

You may not qualify if:

• Has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.
• Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.
• Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
• Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
• Participant is currently receiving flucytosine treatment.
• Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).
• Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome.
• Participant has known brain or leptomeningeal metastases.
• Participant had major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days.
• Participant has any active disease or condition that would not permit compliance with the protocol.
• Participant has clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, New York Heart Association Grade 2 or greater), or uncontrolled serious cardiac arrhythmia.
• Participant has documented cerebrovascular disease.
• Participant has a seizure disorder not controlled with medication (based on Investigator's decision).
• Participant has received an investigational agent within 28 days of enrollment.
• Participant has an uncontrolled active viral, bacterial, or systemic fungal infection.

Sponsors & Collaborators

• InnoPharmax Inc.: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Andy Huang

  InnoPharmax Inc.

  STUDY DIRECTOR

Central Study Contacts

Yuyuan Lin

CONTACT

886-287977607; yuan.lin@innopharmax.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)