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Antibody-drug conjugate

TROP2 ADC for Cancer (A264 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Klus Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas

Must not have

Subjects previously treated with TROP 2 targeted therapies

Severe or uncontrolled cardiac disease requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with cancer that has not responded to available treatments and who have no other options.

Who is the study for?

Adults aged 18-75 with advanced solid tumors that can't be surgically removed or have spread and don't respond to standard treatments. Specific cancers include certain types of breast, ovarian, lung, gastric, head and neck, endometrial, and urothelial cancers. Participants must have acceptable organ function and blood counts, not require oxygen for daily activities or have severe heart conditions.

What is being tested?

SKB264 is being tested in this Phase I-II trial on patients with various advanced solid tumors unresponsive to standard therapies. The study aims to evaluate the safety and effectiveness of SKB264 as a potential treatment option for these patients.

What are the potential side effects?

Potential side effects are not specified here but generally could include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver issues like elevated enzymes or bilirubin levels indicating liver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My kidneys work well enough to clear waste from my blood.

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My cancer is advanced, cannot be cured, and started in the lining of organs.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with TROP 2 targeted therapies before.

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I have a serious heart condition that needs treatment.

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I haven't had cancer treatment in the last 4 weeks or before the study drug's half-life period.

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I need extra oxygen to do my daily activities.

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I haven't had major surgery in the last 4 weeks.

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I have high blood pressure or diabetes that is not well-managed.

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I have severe eye conditions like dry eye, Meibomian gland disease, or macular degeneration.

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I have fluid buildup in my chest causing symptoms.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I have had lung conditions that needed steroids or caused severe breathing problems.

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I have or had liver disease, including hepatitis, alcoholism, or cirrhosis.

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I need a procedure to remove excess fluid from my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 to cycle 6 and end of treatment(eot), approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)

Phase II: Objective Response Rate (ORR)

Secondary study objectives

Phase I: Dose Limiting Toxicities (DLTs)

Phase I: Overall safety and tolerability profile

Phase I: PK parameters for SKB264-ADC, SKB264 TAB, and free KL610023 payload.

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Group I: Phase II: Urothelial carcinomaExperimental Treatment1 Intervention

Histologically or cytologically documented, incurable, locally advanced or metastatic cancer

Group II: Phase II: Triple Negative Breast CancerExperimental Treatment1 Intervention

Histologically documented or cytologically , incurable, locally advanced or metastatic cancer

Group III: Phase II: Non-Small Cell Lung CancerExperimental Treatment1 Intervention