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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination therapy for individuals with advanced biliary tract cancer that cannot be surgically removed. Researchers aim to determine if adding CTX-009, an experimental drug, to the standard treatment increases effectiveness. Participants receive this combination on an outpatient basis, divided into groups. This trial may suit those with confirmed unresectable or metastatic biliary tract cancer who have not yet received treatment for their current stage. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CTX-009 has been tested in patients with advanced biliary tract cancer, yielding promising results. In one study involving 24 patients, 42% responded positively to the treatment, with nearly half experiencing some improvement.

The treatment was generally well-tolerated, though some side effects occurred. While specific side effects were not detailed, the trial's progress suggests they were manageable. CTX-009 remains under study, and more information about its safety may become available.

CTX-009 is being tested alongside other cancer treatments such as durvalumab, gemcitabine, and cisplatin. These combinations might produce different side effects, as each drug has its own. It is important for patients to discuss expectations with their doctors. Overall, current data suggests that CTX-009 could be a safe option for many patients, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CTX-009 for biliary tract cancer because it combines innovative mechanisms with a multi-drug approach. Unlike the standard treatment options, which often involve chemotherapy drugs like gemcitabine and cisplatin, CTX-009 is an investigational drug that may enhance the effectiveness of these existing therapies. Combining CTX-009 with durvalumab, an immunotherapy drug, could potentially boost the body's immune response against cancer cells, offering a new angle in treatment. This multi-faceted approach aims to improve patient outcomes by targeting cancer through different pathways simultaneously.

What evidence suggests that this trial's treatments could be effective for biliary tract cancer?

Research has shown that CTX-009, a special type of antibody, may help treat biliary tract cancer. In earlier studies, about 37.5% of patients with advanced biliary tract cancer experienced tumor shrinkage when treated with CTX-009 and paclitaxel. This is a positive sign. In this trial, participants will receive CTX-009 in combination with Durvalumab, Gemcitabine, and Cisplatin. CTX-009 targets two proteins, DLL4 and VEGF-A, which cuts off the blood supply to tumors and slows their growth. These early findings suggest that CTX-009 could be a useful addition to standard treatments. ^{1 4 5 6 7}

Who Is on the Research Team?

Ian Hu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 agree to use birth control during the study.

I do not have any current infections.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. investors.compasstherapeutics.com investors.compasstherapeutics.com/news-releases/news-release-details/tovecimig-ctx-009-meets-primary-endpoint-ongoing-randomized

Tovecimig (CTX-009) Meets Primary Endpoint in the ... Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel achieved a 17.1% overall response rate (ORR), including one ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/14796694.2024.2351351

COMPANION-002 A clinical trial of investigational drug ... Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody ...

3. dailynews.ascopubs.org dailynews.ascopubs.org/do/responses-seen-advanced-biliary-tract-cancer-treated-ctx-009-plus-paclitaxel

Responses Seen in Advanced Biliary Tract Cancer Treated ... The preliminary results from efficacy outcome measures are summarized in the Table. Overall, 9 participants (37.5%) had confirmed partial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05506943

A Study of CTX-009 in Combination With Paclitaxel in Adult ... This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously ...

5. physicianresources.roswellpark.org physicianresources.roswellpark.org/news/phase-2/3-clinical-trial-for-advanced/metastatic/unresectable-biliary-tract-cancer-builds-on-promising-results-of-earlier-study

Phase 2/3 Clinical Trial for Advanced/Metastatic/ ... This open-label, two-arm, randomized study will compare the efficacy of the combination therapy versus paclitaxel alone in previously treated patients.

6. investors.compasstherapeutics.com investors.compasstherapeutics.com/news-releases/news-release-details/compass-therapeutics-reports-positive-interim-phase-2-data-ctx

News Release Details CTX-009 Demonstrated a 42% Overall Response Rate (ORR) Based on 10 Partial Responses (PRs) in 24 Enrolled Patients. CTX-009 Continues to be ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38861293/

COMPANION-002 A clinical trial of investigational drug CTX ... In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% ...