ADC for Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: MBrace Therapeutics

Must be taking: AR-targeted therapy

Must not be taking: Anticancer therapy, Investigational drugs

Disqualifiers: Other malignancy, Active infections, Cardiac events, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ADC (antibody-drug conjugate) for individuals with advanced cancers that have not responded to standard treatments. It is divided into different phases to determine the correct dosage and assess the treatment's effectiveness. The trial seeks participants with specific types of cancer, such as certain types of prostate, breast, lung, or digestive system cancers, who have already tried standard treatments without success. For those with advanced cancer unresponsive to usual treatments, this trial might be suitable. 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 treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that any anticancer therapy or investigational drug must be stopped 14 days before the first dose of the study drug, and the use of any prohibited concomitant medications is not allowed. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that ADC is likely to be safe for humans?

Research shows that antibody-drug conjugates (ADCs) are often well-tolerated, though some expected and unexpected side effects can occur. ADCs specifically target cancer cells but can still cause significant side effects. This occurs because the treatment combines an antibody (a protein targeting specific cells) with a potent drug. The goal is to deliver the drug directly to cancer cells while avoiding healthy ones.

In some cases, ADCs have been linked to unexpected toxicities, which are side effects that were not anticipated. These can occur even though the drug is designed to minimize harm. As this is an early-stage trial, the focus is on finding the right dose and understanding patient responses to the treatment.

This type of study aims to learn how the treatment affects people. Participants might experience side effects, but researchers closely monitor and manage them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ADC (Antibody-Drug Conjugates) because they offer a targeted approach to treating cancer, which is different from traditional treatments like chemotherapy and radiation. Unlike these conventional methods that affect both cancerous and healthy cells, ADCs specifically target cancer cells, potentially reducing side effects and improving effectiveness. ADCs combine an antibody that recognizes cancer cells with a potent drug, delivering the treatment directly to the tumor. This precision targeting could lead to better outcomes for patients, making ADCs a promising option in the fight against cancer.

What evidence suggests that ADC might be an effective treatment for advanced metastatic solid tumors?

Research has shown that antibody-drug conjugates (ADCs) could effectively treat advanced solid tumors. In earlier studies, 17% of patients experienced tumor shrinkage after using ADCs, and 71% achieved disease control, meaning their cancer did not worsen. ADCs function by attaching antibodies that specifically target cancer cells to drugs that kill these cells, increasing effectiveness while reducing damage to healthy cells. This trial will evaluate ADCs in different phases, including dose escalation and dose expansion, to determine their potential as a strong option for patients with difficult-to-treat cancers. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with advanced metastatic solid tumors like certain breast, lung, colorectal, prostate, and pancreatic cancers that don't respond to standard treatments. Participants must be able to give informed consent and follow study procedures. They should not be pregnant or breastfeeding and must use effective contraception.

Inclusion Criteria

I can read, understand, and agree to the study's consent form.

I agree not to try to become pregnant during and for 6 months after the study.

I agree to use two forms of birth control, including a barrier method, during and for 6 months after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Characterize safety and identify potential optimal biologically relevant doses (OBRDs), Recommended Phase 2 Doses (RP2Ds), and the maximum tolerated dose (MTD) of MBRC-201

21 days

Phase 1b: Dose Expansion

Evaluate the safety and preliminary clinical activity of MBRC-201 at the potential OBRDs, RP2Ds, and dosing regimens identified in Phase 1a

Approximately 24 months

Phase 2

Further evaluate antitumor activity and safety of MBRC-201 at the RP2D determined during Phase 1b

Approximately 24 months

Follow-up

Participants are monitored for safety, disease status, and survival assessments after treatment

Long-term until death or lost to follow-up

What Are the Treatments Tested in This Trial?

Interventions

• ADC

Trial Overview The study tests an Antibody-Drug Conjugate (ADC) in phases: Phase 1a finds the right dose; Phase 1b expands the dose group; Phase 2 checks safety and how the body processes the drug. It's open-label so everyone knows they're getting ADC.

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 1 Intervention

Recommended Phase 2 Dose

Group II: Phase 1b Experimental Treatment 1 Intervention

Dose Expansion

Group III: Phase 1a Experimental Treatment 1 Intervention

Dose Escalation

Who Is Running the Clinical Trial?

MBrace Therapeutics

Lead Sponsor

Trials

1

Recruited

130+

Citations

1. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01704-3

Antibody–Drug Conjugates (ADCs): current and future ... ADCs address the lack of target specificity in traditional chemotherapy, enhance the therapeutic effectiveness of mAbs, and offer potent ...

2. esmoopen.com esmoopen.com/article/S2059-7029(25)01442-5/fulltext

Toxicity and efficacy of antibody–drug conjugates in ... ADCs showed 17% overall response rate and 71% disease control in a heavily pretreated solid tumor cohort. · Topoisomerase payloads achieved ...

3. nature.com nature.com/articles/s41388-025-03448-3

Exploring the therapeutic use and outcome of antibody- ... Antibody-drug conjugates (ADCs) have emerged as a promising therapeutic strategy for treating ovarian cancer (OC), particularly in cases of platinum-resistant ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15003

Comparisons of survival outcomes of antibody-drug- ... This network meta-analysis showed prominent survival benefits with ADC-containing regimens for mBC. Our results provide valuable insights into personalized ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040842823002779

The ever-expanding landscape of antibody-drug ... Currently, 52 phase III clinical trials for ADCs are ongoing. Conclusion. ADCs have shown promising results for several solid tumors and various cancer settings ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6399172/

Safety and Tolerability of Antibody-Drug Conjugates in Cancer Antibody-drug conjugates are usually well tolerated with some predictable adverse reactions, as well as new medical issues, that need careful approach.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842825002537

Safety assessment of antibody-drug conjugates As a complex multi-domain modality, ADC combines highly specific targeting ability of an antibody with the potent toxicity of a chemical payload to tumors ...

8. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01720-3

Treatment-related adverse events of antibody drug-conjugates ... Despite being designed to minimize toxicity, ADCs were associated with significant AEs, including unexpected toxicities unrelated to payloads, ...

9. bioivt.com bioivt.com/blogs/an-introduction-to-antibody-drug-conjugates

Development of Antibody-Drug Conjugates Epitopes expressed uniquely on the cancer cells are generally ideal to reduce off-target toxicity of the ADC, but that is not always the case.

10. nature.com nature.com/articles/s41392-022-00947-7

Antibody drug conjugate: the “biological missile” for ... For example, matrix targeted ADC drugs has the potential to cause cancer cell death by reducing the concentration of growth factors produced by ...