OMTX705 + Pembrolizumab for Cancer

Recruiting at 8 trial locations

Overseen By Ignacio García-Ribas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oncomatryx Biopharma S.L.

Must not be taking: Immunosuppressants, CYP3A4 inhibitors

Disqualifiers: Uncontrolled brain metastasis, Active infection, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests the safety and tolerability of a new drug, OMTX705, for individuals with advanced or metastatic cancer who lack standard treatment options. The trial includes different groups: some will receive OMTX705 alone, while others will receive it with pembrolizumab (also known as KEYTRUDA or MK-3475) or tislelizumab, drugs that assist the immune system in fighting cancer. The trial seeks participants with specific cancers, such as pancreatic, gastric, and certain types of sarcomas, particularly those who have exhausted other treatments. Eligible participants must have a confirmed diagnosis of these cancers and no other treatment options available. As a Phase 1 trial, this research focuses on understanding how OMTX705 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that are strong inhibitors or inducers of specific enzymes at least 14 days before the first dose. If you're taking any of these drugs, you will need to stop them before participating.

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

Research has shown that OMTX705 is generally safe. In earlier studies, patients who received OMTX705, either alone or with pembrolizumab, experienced disease control, even in some difficult-to-treat cancers. This treatment specifically targets certain tumor cells and is designed to be very stable, reducing side effects.

As a Phase 1 study, the main goal is to assess the safety and tolerability of the treatment. This phase marks the first major step in understanding how well patients can handle it. Although detailed information on side effects from the initial studies is not yet available, ongoing research will provide more insights into its safety.

Pembrolizumab is already approved for treating several types of cancer, offering some reassurance about safety when used with OMTX705. However, it is important to remember that these findings are still early, and more information will become available as the study progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about OMTX705 because it offers a new approach to tackling cancer by targeting fibroblast activation protein (FAP), which is often overexpressed in cancer-associated fibroblasts. This mechanism is different from standard chemotherapy or radiation treatments, which typically target rapidly dividing cells. Additionally, OMTX705 is being tested both as a single agent and in combination with checkpoint inhibitors like pembrolizumab and tislelizumab, potentially enhancing the immune system's ability to fight cancer. These combinations could provide a more robust and targeted treatment option, possibly improving outcomes for patients with certain cancers.

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

Research has shown that OMTX705 could be a promising treatment for cancers that don't respond well to current therapies. In earlier studies, OMTX705, when used alone, demonstrated positive effects against solid tumors, particularly those resistant to anti-PD1 immunotherapies. In this trial, some participants will receive OMTX705 as a single agent. Additionally, combining OMTX705 with another drug like paclitaxel produced better results than using either drug alone. Pembrolizumab is already known to help the immune system fight cancer. This trial tests the combination of OMTX705 with pembrolizumab to determine if it enhances effectiveness, especially for difficult-to-treat tumors. These findings offer hope for new ways to address challenging cancer types. ^{1 2 5 6 7}

Who Is on the Research Team?

Ignacio García-Ribas, MD

Principal Investigator

Oncomatryx Biopharm, S.L.

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors without standard treatment options can join this trial. They must have measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children and men with partners who can must use contraception. Exclusions include active infections, certain heart conditions, pregnancy, recent other cancer treatments, uncontrolled brain metastases, and specific medication interactions.

Inclusion Criteria

Serum albumin ≥3.0 g/dL

I am using birth control as required.

My cancer is advanced or has spread and has been confirmed by a biopsy.

Exclusion Criteria

I have brain metastasis that is not under control.

I've had fluid drained from my abdomen or chest 2+ times in the last month.

I have had pneumonitis or lung disease in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Phase 1 dose-escalation with two parallel staggered escalation cohorts to establish the maximum tolerated dose (MTD) or the provisional recommended dose for the expansion phase (RP2D).

21 days per cycle

Visits on Days 1 and 8 of each 21-day cycle

Expansion

Five cohort expansions to confirm the safety of OMTX705 as monotherapy and in combination with tislelizumab, providing additional efficacy and safety information.

Varies by cohort

End of Treatment (EoT)

Evaluation of new adverse events or recovery from previous ones 30 days after the last dose of any component of the treatment.

30 days

Follow-up

Participants are monitored for progression-free survival (PFS) every 12 weeks until progression, loss to follow-up, consent withdrawal, death, or study termination.

Every 12 weeks

Survival Follow-up

Subjects enrolled in Part 2 are followed for survival status every 3 months from the first dose of OMTX705.

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• OMTX705
• Pembrolizumab

Trial Overview

OMTX705 is being tested alone and combined with Pembrolizumab to treat advanced cancers in patients lacking other options. This Phase 1 study will gradually increase doses to find safe levels (dose-escalation) before expanding the number of participants at those levels (expansion phase).

How Is the Trial Designed?

Group I: SCHED1 Experimental Treatment 1 Intervention

Part 2: OMTX705 is administered as single agent at 15 mg/kg

Group II: SARC1 Experimental Treatment 1 Intervention

Part 2: OMTX705 is administered as single agent in FAP positive patients at 10 mg/kg

Group III: PDAC Low Experimental Treatment 2 Interventions

Part 2: OMTX705 is administered at 4.0 mg/kg in combination with tislelizumab at 200 mg

Group IV: PDAC High Experimental Treatment 2 Interventions

Part 2: OMTX705 is administered at 7.5 mg/kg in combination with tislelizumab at 200 mg

Group V: Monotherapy (OMTX705) Experimental Treatment 1 Intervention

Part 1: OMTX705 is administered as single agent at diffrent escalation doses.

Group VI: Combination (OMTX705 + pembrolizumab) Experimental Treatment 2 Interventions

Part 1: OMTX705 at different escalation doses is administered in combination with pembrolizumab at 200 mg.

Group VII: BIOPSY Experimental Treatment 1 Intervention

Part 2: OMTX705 is administered as single agent at 7.5 mg/kg

Who Is Running the Clinical Trial?

Oncomatryx Biopharma S.L.

Lead Sponsor

Trials

1

Recruited

120+

Centro de Investigación del Cáncer Universidad de Salamanca

Collaborator

CTI Laboratory Services Spain

Collaborator

Anapharm Bioanalytics

Collaborator

Trials

1

Recruited

30+

Certara

Industry Sponsor

Trials

3

Recruited

6,800+

Biotrial

Industry Sponsor

Trials

15

Recruited

1,100+

Alcura Health España SA

Collaborator

Clinigen, Inc.

Industry Sponsor

Trials

10

Recruited

360+

Evidenze

Collaborator

TFS Health Science

Collaborator

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3028

First-in-human phase 1 dose escalation trial of OMTX705 ...

Results: A total of 78 pts have been dosed: 31 pts in monotherapy in 9 dose cohorts and 47 in combination in 7 cohorts of 3 pts each plus 2 ...

2.

aacrjournals.org

aacrjournals.org/clincancerres/article/26/13/3420/82545/OMTX705-a-Novel-FAP-Targeting-ADC-Demonstrates

OMTX705, a Novel FAP-Targeting ADC Demonstrates Activity ...

Combination of paclitaxel with OMTX705 at 10 mg/kg was more effective than either drug alone at the same doses. OMTX705 alone at 30 mg/kg showed higher efficacy ...

3.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)49618-X/fulltext

OMTX705, a powerful stroma-targeting ADC to treat ...

OMTX705 is a highly promising candidate to treat different solid tumors with low response to anti-PD1 immunotherapies.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05547321

NCT05547321 | Efficacy and Safety Study of OMTX705, ...

Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in ...

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/oncomatryx-secures-e25m-to-advance-omtx705-clinical-trials/

Oncomatryx Secures €25M to Advance OMTX705 Clinical ...

The €25 million infusion enables Oncomatryx to conduct crucial Phase Ib-II studies for OMTX705, providing critical data on safety, efficacy, and ...

6.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_1/6391/761188/Abstract-6391-OMTX705-A-dual-mechanism-ADC

Abstract 6391: OMTX705: A dual-mechanism ADC targeting ...

OMTX705, a clinical-stage ADC, targets FAP-positive CAFs in the tumor microenvironment. OMTX705 presents an optimized and highly stable linker.

7.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/390335

Efficacy and Safety Study of OMTX705, Monotherapy and ...

Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, ...