Trial Title:
A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors
NCT ID:
NCT06238687
Condition:
Neoplasm Malignant
Conditions: Official terms:
Carcinoma, Ovarian Epithelial
Neoplasms
Conditions: Keywords:
advanced malignant solid tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
STRO-002
Description:
STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal
antibodies with the anti-tumor activity of cytotoxic drugs.
Arm group label:
Cohort 1(Phase I)
Arm group label:
Cohort 2(Phase I)
Arm group label:
Cohort 3(Phase I)
Arm group label:
Cohort A(Phase IIa)
Arm group label:
Cohort B(Phase IIa)
Arm group label:
Cohort C(Phase IIa)
Arm group label:
Cohort D(Phase IIa)
Arm group label:
Cohort E(Phase IIa)
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.
Detailed 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Life expectancy >3 months.
2. Subjects must have at least one measurable lesion (non-radiotherapy field) per
RECIST v1.1.
3. The adverse reactions (ARs) of previous anti-tumor therapy must recover to NCI CTCAE
v5.0 grade ≤ 1 (except for toxicity with no safety risks judged by investigators,
such as 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 of
standard of care, or have no available standard of care, or are intolerable to
standard of care, or have no further approved treatment options available.
7. (Dose expansion)For each cohort, the following criteria should be met: a. Cohorts A
and B (ovarian cancer): High-grade serous epithelial ovarian cancer with a confirmed
pathological diagnosis, fallopian tube cancer, or primary peritoneal carcinoma.b.
Cohort C (endometrial cancer): Endometrial epithelial cancer with a confirmed
pathological diagnosis (endometrioid adenocarcinoma; serous adenocarcinoma;
undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma not
otherwise specified [N.O.S]), and the disease has relapsed or progressed after at
least 1-line of platinum-based chemotherapy regimen or 1-line of
immunotherapy-containing regimen, and no more than 3 lines of treatment regimen
received previously. c. Cohort D (non-small-cell lung cancer): Unresectable locally
advanced or metastatic non-small-cell lung cancer with a confirmed pathological
diagnosis, and previous treatment meets the following criteria: - Patients without
genetic mutations: If they receive 1-line platinumdoublet chemotherapy and
anti-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;
if they 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 4 lines of treatment regimen. - People with genetic mutations: Received
at least 1-line approved targeted therapy, and previously no more than 4 lines of
treatment regimen. d. Cohort E (triple-negative breast cancer): Unresectable locally
advanced or metastatic breast cancer with a confirmed pathological diagnosis, and
the ER, PR, and HER-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+) must undergo FISH testing and the result is negative; they have
previously received at least 1 line but no more than 4 lines of systemic anticancer
therapy.
Exclusion Criteria:
1. Prior treatment with ADCs containing tubulin inhibitors (e.g., mirvetuximab of
Immunogen, XMT-1536 of Mersana, which contains auristain derivatives that inhibit
tubulin polymerization).
2. Previous treatment with other FolRα-targeting drugs.
3. History of severe allergy or anaphylactic reaction to monoclonal antibody therapy or
antibody-related fusion protein treatment.
4. Prior anticancer therapy (prior to initial dose of study drug): Chemotherapy within
3 weeks, PARPi within 2 weeks, other therapeutic anticancer antibodies within 3
weeks, radio- or toxin-immunoconjugate (such as ADCs) within 10 weeks, Chinese
herbal medicine or traditional Chinese medicinal products with anti-tumor
indications within 1 week, radion therapy/major surgery within 4 weeks (the
definition of surgery refers to Grade 3-4 surgeries specified in the Measures for
the Grade Management of Surgery in Medical Institutions issued by the National
Health Commission 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 clinical study). 5. Pre-existing clinically significant ocular disorders
including, but not limited to: Active or chronic corneal disorders, history of
corneal transplantation, or active ocular conditions requiring ongoing
treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular
degeneration requiring intravitreal injections, active diabetic retinopathy with
macular edema, macular degeneration, presence of papilledema and/or visual acuity
reduced, Prior anticancer therapy (prior to initial dose of study drug):
Chemotherapy within 3 weeks, PARPi within 2 weeks, other therapeutic anticancer
antibodies within 3 weeks, radio- or toxin-immunoconjugate (such as ADCs) within 10
weeks, Chinese herbal medicine or traditional Chinese medicinal products with
anti-tumor indications within 1 week, radion therapy/major surgery within 4 weeks
(the definition of surgery refers to Grade 3-4 surgeries specified in the Measures
for the Grade Management of Surgery in Medical Institutions issued by the National
Health Commission 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 clinical study).
5. Pre-existing clinically significant ocular disorders including, but not limited to:
Active or chronic corneal disorders, history of corneal transplantation, or active
ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled
glaucoma, wet age-related macular degeneration requiring intravitreal injections,
active diabetic retinopathy with macular edema, macular degeneration, presence of
papilledema 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., folate
deficiency.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zheng, MD
Phone:
+8618980601950
Email:
lzheng2005618@163.com
Start date:
November 8, 2023
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Tasly Pharmaceutical Group Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Sutro Biopharma, Inc.
Agency class:
Industry
Source:
Tasly Pharmaceutical Group Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06238687
