CTX-009 + Standard Treatment for Biliary Tract Cancer

Overseen By Ian Hu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: HIV, Active infection, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take antiplatelet or anticoagulant drugs within 2 weeks before the trial or during it. It's best to discuss your specific medications with the trial team.

What makes the drug CTX-009 unique for treating biliary tract cancer?

CTX-009 is a novel treatment option for biliary tract cancer, which is an area where current standard chemotherapy has limited benefits. While the specific details of CTX-009's mechanism or administration are not provided, its investigation alongside standard treatment suggests it may offer a new approach or enhance existing therapies. ^{1 2 3 4 5}

Research Team

Ian Hu, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with biliary tract cancers that cannot be removed by surgery or have spread. Participants must meet certain health standards, which are not specified here.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I do not have any current infections.

I agree to use birth control during the study.

Exclusion Criteria

I have recently used blood thinners.

I haven't had any major blood vessel problems in the last 6 months.

Hypersensitivity reactions to investigational product or similar drugs

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive CTX-009, Durvalumab, Gemcitabine, and Cisplatin to assess tolerability and determine the maximum tolerated dose

8 weeks

Weekly visits (outpatient)

Expansion

Participants continue receiving CTX-009, Durvalumab, Gemcitabine, and Cisplatin to evaluate efficacy and safety

6 months

Bi-weekly visits (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CTX-009

Trial Overview The study tests a new treatment combo: CTX-009 plus standard drugs Gemcitabine and Cisplatin, along with Durvalumab, to see if it's better as a first-line therapy for these cancer patients.

Participant Groups

Group I: Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin Experimental Treatment 4 Interventions

Participants will be administered treatment on an outpatient basis

Group II: Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin Experimental Treatment 4 Interventions

Participants will be administered treatment on an outpatient basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Compass Therapeutics, Inc

Collaborator

Trials

1

Recruited

50+

Findings from Research

In a study of 70 patients with unresectable biliary tract cancer (BTC) undergoing chemotherapy, higher pretreatment levels of the biomarker CA 19-9 were associated with a nearly threefold increased risk of early death, indicating its prognostic value.

A decrease in CA 19-9 levels after two treatment courses was predictive of improved survival, but this association was only significant in patients who did not receive biliary stenting, highlighting the importance of treatment context in interpreting CA 19-9 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic relevance of carbohydrate antigen 19-9 levels in patients with advanced biliary tract cancer. Harder, J., Kummer, O., Olschewski, M., et al.[2022]

In a study of 109 patients with biliary tract cancers who underwent surgery, the CA19-9/TBIL ratio (CTR) was found to be an independent prognostic factor for overall survival, indicating its potential as a useful predictor in clinical settings.

Higher CTR values were significantly associated with shorter overall survival rates, highlighting the importance of this ratio in assessing patient prognosis after surgical resection for biliary tract cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prognostic Value of the CA19-9/TBIL Ratio in Patients with Biliary Tract Cancers (BTCs): A Retrospective Study. Xiao, J., Wang, L., Hong, T., et al.[2022]

Adjuvant capecitabine has been shown to significantly improve overall survival in patients with resected biliary tract cancer compared to observation, based on a phase III trial (BILCAP).

In metastatic biliary tract cancer, the combination of gemcitabine and S-1 or the triplet regimen of gemcitabine, cisplatin, and S-1 (GCS) demonstrated noninferior and superior overall survival, respectively, compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the treatment of biliary tract cancers. Uson Junior, PLS., Bogenberger, J., Borad, MJ.[2021]

In a study of 176 patients with advanced biliary tract cancer, the combination of capecitabine and cisplatin showed moderate efficacy, with a 17% partial response rate and a median overall survival of 7.4 months.

The study found that changes in CA19-9 levels were significantly correlated with both time-to-progression and overall survival, suggesting that CA19-9 could be a useful marker for monitoring treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study. Woo, SM., Lee, WJ., Han, SS., et al.[2015]

In a study of 40 patients with advanced biliary tract cancer who had previously progressed on standard chemotherapy, pembrolizumab demonstrated a modest objective response rate of 10% to 12.5%, indicating some effectiveness as a second-line or later treatment option.

Patients with a tumor proportion score of 50% or higher had significantly better response rates, suggesting that higher PD-L1 expression may predict better outcomes with pembrolizumab, and those who responded experienced a durable response lasting an average of 6.3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. Kang, J., Jeong, JH., Hwang, HS., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prognostic relevance of carbohydrate antigen 19-9 levels in patients with advanced biliary tract cancer. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

The Prognostic Value of the CA19-9/TBIL Ratio in Patients with Biliary Tract Cancers (BTCs): A Retrospective Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Advances in the treatment of biliary tract cancers. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study. [2015]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. [2020]