1300 Participants Needed

TROP2 ADC for Cancer

(A264 Trial)

Recruiting at 147 trial locations
SM
Overseen ByStudy Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: 1. Triple negative breast cancer 2. Epithelial ovarian cancer 3. Non-small cell lung cancer 4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma 5. Small cell lung cancer 6. HR+/ HER2-breast cancer 7. Head and neck squamous cell carcinoma 8. Endometrial carcinoma 9. Urothelial carcinoma

Will I have to stop taking my current medications?

The trial requires that you stop any standard cancer therapy or experimental therapy at least 4 weeks or five half-lives before starting the study drug. Additionally, you cannot use strong inhibitors or inducers of CYP3A4 at least 14 days prior to and throughout the study.

What makes the drug SKB264 (MK-2870) unique for cancer treatment?

SKB264 (MK-2870) is unique because it targets Trop-2, a protein overexpressed in many cancers, using an antibody-drug conjugate (ADC) approach. This allows it to deliver chemotherapy directly to cancer cells, potentially reducing side effects and improving effectiveness compared to traditional chemotherapy.12345

Research Team

JR

Jordi Rodon Ahnert, MD, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patients must be able to provide documented voluntary informed consent
Your white blood cell count, platelet count, and hemoglobin levels are within a certain range.
I am fully active or can carry out light work.
See 10 more

Exclusion Criteria

I haven't taken any experimental drugs within the last 4 weeks.
The investigator considers other situations that patients are not appropriate to participate in this trial
I have been treated with TROP 2 targeted therapies before.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Dose Escalation

Participants receive SKB264 as a single IV infusion at escalating dose levels to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDEs).

12 months
Every 2 weeks in 4-week cycles

Phase II: Treatment

Participants receive SKB264 at the recommended dose levels for expansion to evaluate the objective response rate (ORR) and other efficacy measures.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall survival.

4 weeks

Treatment Details

Interventions

  • SKB264
Trial OverviewSKB264 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.
Participant Groups
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
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group IV: Phase II: Head and Neck Squamous Cell CarcinomaExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group V: Phase II: HR+/ HER2- Breast CancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group VI: Phase II: Gastric Adenocarcinoma or Gastroesophageal Junction AdenocarcinomaExperimental Treatment1 Intervention
Histologically or cytologically documented, incurable, locally advanced or metastatic cancer
Group VII: Phase II: Extensive-stage Small Cell Lung CancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group VIII: Phase II: Epithelial Ovarian CancerExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group IX: Phase II: Endometrial carcinomaExperimental Treatment1 Intervention
Histologically documented or cytologically, incurable, locally advanced or metastatic cancer
Group X: Phase II: Cervical CancerExperimental Treatment1 Intervention
Histologically or cytologically documented, incurable, locally advanced or metastatic cancer
Group XI: Phase I: Dose EscalationExperimental Treatment1 Intervention
Five dose levels have been selected for evaluation in the Phase I part of the study: 2, 4, 6, 9, and 12 mg/kg of SKB264

SKB264 is already approved in China, European Union, United States for the following indications:

🇨🇳
Approved in China as SKB264 for:
  • Triple-negative breast cancer
  • EGFR-mutated non-small cell lung cancer
🇪🇺
Approved in European Union as SKB264 for:
  • Clinical trials approved but no specific indications listed yet
🇺🇸
Approved in United States as SKB264 for:
  • Clinical trials ongoing but no specific indications approved yet

Find a Clinic Near You

Who Is Running the Clinical Trial?

Klus Pharma Inc.

Lead Sponsor

Trials
4
Recruited
2,100+

Findings from Research

Trop-2 is a promising target for cancer treatment because it is overexpressed in many tumor types, making it suitable for targeted therapies like antibody-drug conjugates (ADCs).
Early-phase clinical trials have shown that Trop-2-targeted ADCs are safe and effective, particularly in hard-to-treat cancers such as triple-negative breast cancer and small-cell lung cancer.
Targeting Trop-2 in solid tumors: future prospects.Zaman, S., Jadid, H., Denson, AC., et al.[2023]
Trophoblast surface antigen 2 (Trop-2) is a promising target for cancer therapy due to its high expression in various tumors compared to normal tissues, playing a key role in tumor growth and progression.
Antibody-drug conjugates (ADCs) targeting Trop-2, such as Sacituzumab Govitecan and Datopotamab Deruxtecan, have shown strong antitumor activity and potential for enhancing the effectiveness of other cancer treatments by reprogramming the tumor microenvironment.
Targeting Trop-2 in cancer: Recent research progress and clinical application.Qiu, S., Zhang, J., Wang, Z., et al.[2023]
Trop2 is a glycoprotein that is overexpressed in many cancers, playing a role in cell self-renewal and survival, and its overexpression is linked to drug resistance, making it a significant prognostic biomarker.
Therapeutic strategies targeting Trop2, including antibodies and nanoparticles, have shown promising results in pre-clinical studies by significantly inhibiting tumor growth, with ongoing clinical trials exploring its efficacy in treating epithelial cancers.
Trop2 and its overexpression in cancers: regulation and clinical/therapeutic implications.Shvartsur, A., Bonavida, B.[2022]

References

Targeting Trop-2 in solid tumors: future prospects. [2023]
Targeting Trop-2 in cancer: Recent research progress and clinical application. [2023]
Trop2 and its overexpression in cancers: regulation and clinical/therapeutic implications. [2022]
[Expression and clinical significance of Trop-2 in human pancreatic cancer]. [2011]
Advances in Trop2-targeted therapy: Novel agents and opportunities beyond breast cancer. [2023]