A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors

Last updated: February 1, 2024
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

STRO-002

Clinical Study ID

NCT06238687
TSL-B2276-1-01
  • Ages > 18
  • All Genders

Study Summary

This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Life expectancy >3 months.
  2. Subjects must have at least one measurable lesion (non-radiotherapy field) per RECISTv1.1.
  3. The adverse reactions (ARs) of previous anti-tumor therapy must recover to NCI CTCAEv5.0 grade ≤ 1 (except for toxicity with no safety risks judged by investigators, suchas alopecia).
  4. For adequate bone marrow reserve and organ function.
  5. Calculated QT interval corrected for heart rate using Fridericia correction formula (QTcF), screening and C1D1 predose ECG must be < 500 msec.
  6. (Dose escalation + PK bridging)Relapsed and/or progressed at least one prior line ofstandard of care, or have no available standard of care, or are intolerable tostandard of care, or have no further approved treatment options available.
  7. (Dose expansion)For each cohort, the following criteria should be met: a. Cohorts Aand B (ovarian cancer): High-grade serous epithelial ovarian cancer with a confirmedpathological diagnosis, fallopian tube cancer, or primary peritoneal carcinoma.b.Cohort C (endometrial cancer): Endometrial epithelial cancer with a confirmedpathological diagnosis (endometrioid adenocarcinoma; serous adenocarcinoma;undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma nototherwise specified [N.O.S]), and the disease has relapsed or progressed after atleast 1-line of platinum-based chemotherapy regimen or 1-line ofimmunotherapy-containing regimen, and no more than 3 lines of treatment regimenreceived previously. c. Cohort D (non-small-cell lung cancer): Unresectable locallyadvanced or metastatic non-small-cell lung cancer with a confirmed pathologicaldiagnosis, and previous treatment meets the following criteria: - Patients withoutgenetic mutations: If they receive 1-line platinumdoublet chemotherapy andanti-PD-1/PD-L1 combination at the same time, they have previously received at least 1-line treatment in the past and totally no more than 4 lines of treatment regimen; ifthey have received platinum-doublet chemotherapy sequentially and anti-PD-1/PD-L1,they have previously received at least 2-line treatment and totally no more than 4lines of treatment regimen. - People with genetic mutations: Received at least 1-lineapproved targeted therapy, and previously no more than 4 lines of treatment regimen.d. Cohort E (triple-negative breast cancer): Unresectable locally advanced ormetastatic breast cancer with a confirmed pathological diagnosis, and the ER, PR, andHER-2 are all negative. ER and PR negative are defined as: IHC ER < 1%, IHC PR < 1%.HER-2 negative is defined as: IHC HER-2 (-) or (1+). Patients with HER-2 (2+) mustundergo FISH testing and the result is negative; they have previously received atleast 1 line but no more than 4 lines of systemic anticancer therapy.

Exclusion

Exclusion Criteria:

  1. Prior treatment with ADCs containing tubulin inhibitors (e.g., mirvetuximab ofImmunogen, XMT-1536 of Mersana, which contains auristain derivatives that inhibittubulin polymerization).
  2. Previous treatment with other FolRα-targeting drugs.
  3. History of severe allergy or anaphylactic reaction to monoclonal antibody therapy orantibody-related fusion protein treatment.
  4. Prior anticancer therapy (prior to initial dose of study drug): Chemotherapy within 3weeks, PARPi within 2 weeks, other therapeutic anticancer antibodies within 3 weeks,radio- or toxin-immunoconjugate (such as ADCs) within 10 weeks, Chinese herbalmedicine or traditional Chinese medicinal products with anti-tumor indications within 1 week, radion therapy/major surgery within 4 weeks (the definition of surgery refersto Grade 3-4 surgeries specified in the Measures for the Grade Management of Surgeryin Medical Institutions issued by the National Health Commission of the PRC onDecember 06, 2022) or are in the recovery period from surgery (the investigator judgesthat there are still risks in participating the clinical study). 5. Pre-existingclinically significant ocular disorders including, but not limited to: Active orchronic corneal disorders, history of corneal transplantation, or active ocularconditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wetage-related macular degeneration requiring intravitreal injections, active diabeticretinopathy with macular edema, macular degeneration, presence of papilledema and/orvisual acuity reduced, Prior anticancer therapy (prior to initial dose of study drug):Chemotherapy within 3 weeks, PARPi within 2 weeks, other therapeutic anticancerantibodies within 3 weeks, radio- or toxin-immunoconjugate (such as ADCs) within 10weeks, Chinese herbal medicine or traditional Chinese medicinal products withanti-tumor indications within 1 week, radion therapy/major surgery within 4 weeks (thedefinition of surgery refers to Grade 3-4 surgeries specified in the Measures for theGrade Management of Surgery in Medical Institutions issued by the National HealthCommission of the PRC on December 06, 2022) or are in the recovery period from surgery (the investigator judges that there are still risks in participating the clinicalstudy).
  5. Pre-existing clinically significant ocular disorders including, but not limited to:Active or chronic corneal disorders, history of corneal transplantation, or activeocular conditions requiring ongoing treatment/monitoring, such as uncontrolledglaucoma, wet age-related macular degeneration requiring intravitreal injections,active diabetic retinopathy with macular edema, macular degeneration, presence ofpapilledema and/or visual acuity reduced, blurred vision, conjunctivitis, keratitis,cataracts with significant visual impairment, uveitis, Sjogren syndrome, and dry eye. Patients who are required to take folic acid-containing supplements, e.g., folatedeficiency.

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: STRO-002
Phase: 1/2
Study Start date:
November 08, 2023
Estimated Completion Date:
December 30, 2027

Study Description

This study consists of two parts, Phase I (dose escalation and PK bridging) and Phase IIa (dose expansion). Subjects in each cohort of Phase I will be administered 3 scheduled dose levels of STRO-002 as monotherapy by intravenous infusion until intolerable toxicity, radiographic disease progression, or subject withdrawal for other reasons. 5 dose arms are tentatively set based on the available safety, PK and efficacy data of STRO-002 for the Phase IIa (dose expansion).

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.