NCT04152499|Active Not RecruitingPhase 1FDA Drug

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

MK-2870-001

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

Klus Pharma Inc.ClinicalTrials.gov

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1 other identifier

KL264-01

Study Type

interventional

Target

1,410

Locations

6 countries

Sites

109

Timeline

RegisteredNov 2019

StartedFeb 2020

CompletionJul 2026

Brief Summary

A Phase I-II, First-in-Human Study of SKB264 (Sac-TMT; MK-2870) 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
10.Cervical cancer

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,410

participants targeted

Target at P75+ for phase_1

Timeline

3mo left

Started Feb 2020

Longer than P75 for phase_1

Geographic Reach

6 countries

109 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

Study Progress97%

Feb 2020Jul 2026

First Submitted

Initial submission to the registry

October 29, 2019

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed

4 months until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2026

Expected

Last Updated

May 20, 2025

Status Verified

June 1, 2024

Enrollment Period

5.8 years

First QC Date

October 29, 2019

Last Update Submit

May 15, 2025

Conditions

Epithelial Ovarian Cancer Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Urothelial Carcinoma Non-Small Cell Lung Cancer Small-Cell Lung Cancer Endometrial Carcinoma Head and Neck Squamous Cell Carcinoma Breast Cancer Cervical Cancer

Keywords

TROP2, ADC

Outcome Measures

Primary Outcomes (2)

Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Assess up to 12 months
Phase II: Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of SKB264 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (15)

Phase I: Dose Limiting Toxicities (DLTs)
Day 28 days after first infusion of study drug
Phase I: Overall safety and tolerability profile
from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first
Phase I: Preliminary efficacy based on ORR (Objective Response Rate)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Preliminary efficacy based on DOR(Duration of Response)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
Phase I: Preliminary efficacy based on PFS(Progression-Free Survival)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, approximately 12 months
+10 more secondary outcomes

Study Arms (11)

Phase I: Dose Escalation

EXPERIMENTAL

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

Drug: SKB264

Phase II: Triple Negative Breast Cancer

EXPERIMENTAL

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

Drug: SKB264

Phase II: Epithelial Ovarian Cancer

EXPERIMENTAL

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

Drug: SKB264

Phase II: Non-Small Cell Lung Cancer

EXPERIMENTAL

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

Drug: SKB264

Phase II: Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

EXPERIMENTAL

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

Drug: SKB264

Phase II: Extensive-stage Small Cell Lung Cancer

EXPERIMENTAL

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

Drug: SKB264

Phase II: HR+/ HER2- Breast Cancer

EXPERIMENTAL

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

Drug: SKB264

Phase II: Head and Neck Squamous Cell Carcinoma

EXPERIMENTAL

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

Drug: SKB264

Phase II: Endometrial carcinoma

EXPERIMENTAL

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

Drug: SKB264

Phase II: Urothelial carcinoma

EXPERIMENTAL

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

Drug: SKB264

Phase II: Cervical Cancer

EXPERIMENTAL

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

Drug: SKB264

Interventions

SKB264DRUG

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Also known as: MK-2870, Sacituzumab Tirumotecan (Sac-TMT)

Phase I: Dose EscalationPhase II: Cervical CancerPhase II: Endometrial carcinomaPhase II: Epithelial Ovarian CancerPhase II: Extensive-stage Small Cell Lung CancerPhase II: Gastric Adenocarcinoma or Gastroesophageal Junction AdenocarcinomaPhase II: HR+/ HER2- Breast CancerPhase II: Head and Neck Squamous Cell CarcinomaPhase II: Non-Small Cell Lung CancerPhase II: Triple Negative Breast CancerPhase II: Urothelial carcinoma

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Phase I:
Patients must be able to provide documented voluntary informed consent.
Male or female patient aged 18-75 years.
Histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include but not limited to the following tumor types:
Breast cancer Ovarian epithelial cancer Non-small cell lung cancer Gastric adenocarcinoma Small cell lung cancer Urothelial carcinoma Note: Confirmation of TROP2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from fresh or archived materials for determination of TROP2 expression.
Measurable disease by CT/MRI during dose escalation.
Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or standard treatment is not applicable at this stage.
Granulocyte count ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN.
Serum bilirubin ≤ 1.5 mg/dL (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ×ULN may be enrolled)., aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN), with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic and/or bone metastases (alkaline phosphatase ≤ 5 × ULN).
Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas. Note that 24 hour urine collection is not required but is allowed.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment. Female and male patient treated with SKB264 should continue contraception use for 7 months after the last dose. Such methods include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this clinical trial if they have a partner of childbirth potential. Male patients must always use a condom.
Women are excluded from birth control if they had had tubal ligation or a hysterectomy.
+27 more criteria

You may not qualify if:

Patients that meet the following criteria will be excluded from entry into the study:
Phase I:
Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
Symptomatic brain metastases or any radiation or surgery for brain metastases within 1 months of first infusion of study drug.
Subjects with second primary cancers (except for cured in situ non-melanoma skin cancer and in situ cervical cancer with no relapse in the last 3 years).
Require supplemental oxygen for daily activities.
Documented Grade ≥ 2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, corneal disease that prevents/delays corneal healing, macular degeneration.
Subjects previously treated with TROP 2 targeted therapies.
Any standard cancer therapy (e.g. chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment, or therapy with traditional Chinese medicines approved for anti-tumor treatment, etc.) within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.
Any experimental therapy within 4 weeks or five half-lives, whichever is shorter, of first infusion of study drug.
Any major surgical procedure within 4 weeks of first infusion of study drug.
Diagnosed active liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis.
Have known prior positive test results or medical history for human immunodeficiency virus.
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or diabetes (HbA1c ≥ 9.0%).
+34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Klus Pharma Inc.lead

Study Sites (109)

Los Angeles Hematology Oncology Medical Group

Glendale, California, 91204, United States

Location

University of California Los Angeles

Los Angeles, California, 90404, United States

Location

Florida Cancer Specialists and Research Institute

Sarasota, Florida, 34232, United States

Location

START MidWest

Grand Rapids, Michigan, 49546, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Providence Cancer Institute, Franz Clinic

Portland, Oregon, 97213, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, Canada

Location

MUHC,Glen - Women's Health Research Unit

Montreal, Quebec, Canada

Location

Centro de Estudios Clínicos SAGA

Providencia, Chile

Location

Centro de Investigacion Clinica Bradford Hill

Santiago, Chile

Location

Pontificia Universidad Catolica de Chile - CICUC

Santiago, Chile

Location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

Anhui Cancer Hospital

Hefei, Anhui, China

Location

AnHui Provincial Cancer Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Cancer Hospital