ABL103 + Pembrolizumab for Cancer

Recruiting at 5 trial locations

Overseen By Dayoung Ok

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ABL Bio, Inc.

Must not be taking: Corticosteroids, Immunotherapy

Disqualifiers: Radiotherapy, Bowel obstruction, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments: ABL103 (an experimental treatment) and pembrolizumab (an immunotherapy drug), to determine their safety and effectiveness against advanced or metastatic solid tumors. Some participants will also receive an additional drug called taxane. The trial seeks individuals with solid tumors that cannot be surgically removed or have spread, and who have not responded to standard treatments. Participants should be able to perform daily activities and must have recovered from any side effects of previous treatments. 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 combination therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you must recover from any side effects of previous cancer treatments before starting the study drug. 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 is investigating the safety of combining ABL103 and pembrolizumab, with or without the chemotherapy drug taxane, for treating advanced or spreading solid tumors. Although earlier studies have provided limited information on ABL103, current trials are in the early stages, focusing on safety and determining the correct dose.

Pembrolizumab, already approved for various cancers, has a known safety record and is generally well-tolerated, though some individuals may experience side effects like tiredness or skin problems.

Taxane, a common chemotherapy drug, can enhance treatment effectiveness but may also increase the risk of side effects such as low blood cell counts or hair loss.

In summary, while pembrolizumab and taxane have established safety records in other applications, ABL103 remains under study. Safety is the primary concern in these early trials, and researchers will closely monitor participants to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because ABL103 works in combination with pembrolizumab and taxanes to potentially enhance anti-cancer effects. Unlike traditional therapies that might focus solely on one pathway, ABL103 uniquely targets multiple cancer-related processes, possibly improving effectiveness. Pembrolizumab, an established immunotherapy, is combined with ABL103 to potentially boost the immune system's ability to fight cancer. Additionally, the inclusion of taxanes, a common chemotherapy agent, might help in disrupting cancer cell growth more efficiently. This multi-faceted approach could offer a new avenue for treatment, providing hope for better outcomes in cancer therapy.

What evidence suggests that this trial's treatments could be effective for advanced or metastatic solid tumors?

Research has shown that combining ABL103 with pembrolizumab (also known as KEYTRUDA) may help treat advanced or spreading solid tumors. ABL103 is a special type of antibody that aids the immune system by activating T cells, which are white blood cells that fight infections and cancer. Early results suggest that this combination might slow tumor growth while keeping side effects manageable. In this trial, some participants will receive ABL103 and pembrolizumab, while others will receive ABL103, pembrolizumab, and taxane, a type of chemotherapy, which could enhance these effects. Although more research is needed, using these treatments together might offer a promising way to slow tumor progression. ^{1 3 4 5 6}

Who Is on the Research Team?

Sangmi Lee

Principal Investigator

ABL Bio

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors who have not responded to standard therapy, are intolerant to it, or have relapsed. Participants must be in good physical condition (ECOG 0-1), have recovered from previous treatment side effects (except stable Grade 2 issues), and possess adequate organ function. Women of childbearing potential and men with partners must agree to use contraception.

Inclusion Criteria

Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions

My cancer is advanced, cannot be surgically removed, or has spread.

I am 18 years or older.

Exclusion Criteria

I've had cancer treatment with a monoclonal antibody or experimental therapy less than 28 days ago.

I had radiotherapy less than 2 weeks ago or need steroids for radiation side effects.

I stopped immunotherapy due to severe side effects, except for manageable hormone issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in Part 1

Safety assessment of ABL103 in combination with pembrolizumab

4-6 weeks

Safety Lead-in Part 2

Safety assessment of ABL103 in combination with pembrolizumab and taxane

4-6 weeks

Dose-expansion Part

Evaluation of antitumor activity of ABL103 in combination with pembrolizumab and taxane

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABL103
• Pembrolizumab
• Taxane

Trial Overview The trial is evaluating the safety and effectiveness of ABL103 combined with pembrolizumab, an immunotherapy drug, with or without a chemotherapy agent called taxane in treating various advanced cancers. The study will monitor how well patients respond to this combination therapy.

How Is the Trial Designed?

Group I: Group 2) ABL103 + pembrolizumab + taxane Experimental Treatment 3 Interventions

Dose-expansion Part

Group II: Group 1) ABL103 + pembrolizumab + taxane Experimental Treatment 3 Interventions

Dose-expansion Part

Group III: ABL103 (DL2-1) + pembrolizumab + taxane Experimental Treatment 3 Interventions

Safety Lead-in Part 2

Group IV: ABL103 (DL2) + pembrolizumab + taxane Experimental Treatment 3 Interventions

Safety Lead-in Part 2

Group V: ABL103 (DL1) + pembrolizumab Experimental Treatment 2 Interventions

Safety Lead-in Part 1

Who Is Running the Clinical Trial?

ABL Bio, Inc.

Lead Sponsor

Trials

6

Recruited

390+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07158918

Study Details | NCT07158918 | ABL103 in Combination ... This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid ...

2. biospace.com biospace.com/press-releases/abl-bio-announces-clinical-collaboration-to-evaluate-abl103-in-combination-with-keytruda-pembrolizumab-in-patients-with-solid-tumors

ABL Bio Announces Clinical Collaboration to Evaluate ... ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA.

3. synapse.patsnap.com synapse.patsnap.com/blog/abl-bio-to-collaborate-on-testing-abl103-with-keytruda-pembrolizumab-for-solid-tumor-patients

ABL Bio to Collaborate on Testing ABL103 ... We anticipate that combining ABL103 with KEYTRUDA will enhance the lives of patients with advanced or metastatic solid tumors. So far, the phase ...

4. withpower.com withpower.com/trial/phase-2-tumors-solid-7-2025-3fca8

ABL103 + Pembrolizumab for Cancer This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors. Show ...

5. ablbio.com ablbio.com/en/company/news_view/831?keyword=&sort_desc=date

News Through this study, ABL Bio aims to evaluate the safety and efficacy of the ABL103 triple combination therapy. Sang Hoon Lee, CEO of ABL Bio ...

6. prnewswire.com prnewswire.com/news-releases/abl-bio-announces-clinical-collaboration-to-evaluate-abl103-in-combination-with-keytruda-pembrolizumab-in-patients-with-solid-tumors-302267530.html

ABL Bio Announces Clinical Collaboration to Evaluate ... ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA.