A Phase I/II, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Immunogenicity of TJ102 in Participants With Advanced or Metastatic Ovarian Cancer and Other Solid Tumors.
Study Identifier:
TJ102-I-II-001-G
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Will Be Recruiting
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Study Summary
The goal of this clinical trial is to evaluate whether TJ102, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced ovarian or other solid tumors. The main objectives of this study are : • To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ102 • to show preliminary antitumor activity in patients with advanced ovarian or other solid tumors. Participants will: • Receive intravenous (IV) infusions of TJ102 at escalating dose levels (during dose escalation) or at the selected expansion dose. • Undergo regular tumor imaging to assess response. • Provide blood samples for pharmacokinetics (PK) and biomarker analysis. • Be monitored for side effects and overall tolerability. This study is being conducted in adult patients with advanced or metastatic ovarian or other solid tumors who have exhausted standard treatment options.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Ovarian
Fallopian Tube
Primary Peritoneal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: TJ102
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Drug: TJ102 will be infused intravenously once every 3 weeks. Participants will receive TJ102 at escalating dose levels (during dose escalation) or at the selected expansion dose
Drug: Drug: TJ102
Drug: TJ102 is a CDH6/FRa directed antibody conjugate with dual payloads
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
Inclusion criteria
- 1. Has histologically or cytologically documented locally advanced or metastatic high-grade serous epithelial ovarian cancer, including ovarian, fallopian tube, or primary peritoneal carcinoma, that is not amenable to curative surgery or radiotherapy, and has demonstrated radiographic disease progression on the most recent line of systemic therapy.
- 2. Prior exposure to a platinum-containing regimen is mandatory. Platinum-resistant disease is defined as disease progression during or within 6 months following completion of the most recent platinum-containing regimen. Patients with platinum-sensitive disease may be eligible during Phase 1 if they have received at least 2 prior lines of platinum-containing systemic therapy.
- 3. Prior Lines of therapy:
- Subjects must have received at least one (≥1) and no more than four (≤4) prior lines of systemic therapy in the advanced or metastatic setting and have progressed on, been intolerant to, or be ineligible for standard therapies available in their local region. Prior treatment with mirvetuximab soravtansine and/or bevacizumab is permitted but not required, reflecting regional differences in standard of care, regulatory approval status, availability, or access.
- Hormonal therapy and maintenance therapy, including PARP inhibitors or bevacizumab maintenance, are not counted as prior lines of systemic therapy unless administered for treatment of progressive disease.
- 4. Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors;
- 5. ≥18 years old;
- 6. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1;
- 7. Life expectancy of ≥12 weeks;
- 8. Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing;
- Main
Exclusion criteria
- 1. Has know hypersensitivity to any component of TJ102 or has a history of severe hypersensitivity reactions to other monoclonal antibodies.
- 2. Has received more than two (2) prior antibody-drug conjugate (ADC) therapies in the advanced or metastatic disease setting, including ADCs containing topoisomerase I inhibitor payloads (e.g., SN-38, DXd, exatecan derivatives) or antimicrotubule payloads (e.g., MMAE, DM1/DM4, auristatins, maytansinoids).
- 3. Prior therapy with any antibody-drug conjugate (ADC) whose cytotoxic payload is eribulin or a structural derivative thereof is prohibited in the advanced/metastatic disease setting.
- 4. Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ102; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ102;
- 5. Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives prior to first dose of TJ102;
- 6. Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ102; Current participation in other interventional clinical studies (participation in survival follow-up is allowed);
- 7. Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V6.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing loss) that will not increase the safety risk may be eligible per the discretion of the Investigator;
- 8. Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis can't be ruled out by imaging at screening;
- 9. Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator;
- 10. Presence of Grade ≥2 or history of Grade ≥3 peripheral neuropathy.
- 11. Uncontrolled or significant cardiovascular disease
- 12. For patients with documented positive virology status, as confirmed by Screening hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) tests, only the following patients may be eligible as evaluated by the sponsor and investigator:
- Patients with active hepatitis B: HBV DNA ≤500 IU/mL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), should have controlled infection (HCV RNA≤ULN by polymerase chain reaction [PCR] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician.
- 13. Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease) within two weeks prior to starting study treatment.
- 14. Active central nervous system (CNS) metastases or meningeal metastases. Subjects may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks (i.e., imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg/day (or equivalent dose). Subjects with untreated CNS metastases are excluded.
- 15. Other malignancies within 3 years prior to initiation of study treatment (Note: does not include tumors with a negligible risk for metastasis or death, eg, non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and without evidence of disease recurrence);
- 16. Female patients who are lactating or breastfeeding;
- 17. The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Will Be Recruiting
Condition(s) Treated at Site
Ovarian
Fallopian Tube
Primary Peritoneal
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site
Ovarian
Fallopian Tube
Primary Peritoneal
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Ovarian
Fallopian Tube
Primary Peritoneal