A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    78
  • sponsor
    THERAPIM PTY LTD
Updated on 4 October 2022
platelet count
measurable disease
carcinoma
doxorubicin
metastasis
neutrophil count
carboplatin
bevacizumab
cancer chemotherapy
fallopian tube
platinum-based chemotherapy
endometrioid adenocarcinoma
peritoneal cancer
ovarian epithelial carcinoma

Summary

This is a Phase 1b/2a multicenter study, which consists of two parts:

Part 1: the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). ATX-101 will be administered intravenously in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. In the case where 20 mg/m² is not tolerated, the dose can be de-escalated to 15 mg/m².

Part 2: the Phase 2a part of the study will investigate the efficacy and safety of ACD.

ATX-101 will be administered at the dose defined in Part 1 of the study.

Treatment will continue up to six cycles or until disease progression or unacceptable toxicity, participant withdrawal of consent, non-compliance, lost to follow-up, or withdrawal at the Investigators discretion, whichever occurs first.

Details
Condition Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, High Grade Serious or Endometrioid Carcinoma of the Ovary, Fallopian Tube, or Primary Peritoneal Cancer
Treatment ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)
Clinical Study IdentifierNCT04814875
SponsorTHERAPIM PTY LTD
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women ≥ 18 years of age
Is not a woman of childbearing potential
Surgically sterile (i.e., had a bilateral tubal ligation, hysterectomy, salpingectomy, or bilateral oophorectomy at least 6 months prior to Day 1 of the study) or
Postmenopausal for at least 1 year prior to Day 1 of the study, and have follicle stimulating hormone levels in the postmenopausal range for the study site
Signed written informed consent
Histologically confirmed high grade serous or endometrioid carcinoma of the ovary, fallopian tube, or primary peritoneal cancer
1 to 3 prior systemic treatment lines. Prior maintenance therapy with bevacizumab or PARP inhibitors is permitted
Platinum-sensitive carcinoma, defined as disease progression after ≥ 6 months following the most recent platinum-based therapy of the disease
Measurable disease on CT/MRI scan according to RECIST 1.1
ECOG Performance status 0 to 1
Life expectancy of at least 6 months
Meet the following laboratory requirements
Hemoglobin (HGB) ≥ 100 × 109/L
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelet count ≥ 100 × 109/L
aPTT/PT ≤ 1.5 x ULN
Total bilirubin level ≤ 1.5 × ULN
AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis present)
Creatinine Clearance > 60 mL/min, as calculated by Cockcroft-Gault formula, or serum creatinine ≤ 1.5 × ULN

Exclusion Criteria

Have received an anti-cancer/investigational drug within 4 weeks prior to study drug administration
Have received a vaccine for COVID-19 within 14 days prior to the first dose of ATX-101 or are scheduled/intend to have a COVID-19 vaccine on Day 1 or during the DLT period (i.e. C1D2 [Day 2] through to C2D2 [Day 30]) of the study
Have not recovered from AEs (≥ CTCAE Grade 2 other than alopecia) due to agent(s) administered more than 4 weeks earlier
Radiotherapy within 4 weeks prior to study drug administration
Major surgery or significant trauma within 28 days (4 weeks) of Screening
Anticipated requirement for surgery or initiation of anti-cancer therapy, other than described in this study protocol, during the study period
Known hypersensitivity to any of the combination partners of ATX-101
Any malignancy over the last 5 years, other than ovarian/fallopian tube/primary peritoneal cancer, with exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that is considered cured by excision
Cardiac failure NYHA III/IV
LVEF < 50% (ECHO or MUGA must not be older than 12 weeks)
QTcF > 470 msec
Any organ dysfunction or current acute or chronic disease, other than the study indication, that would significantly increase the expected risk in participants participating in the study, in the judgment of the Investigator
Pregnant or breast-feeding women
Unwilling or unable to follow protocol requirements
A past positive status of HIV and/or positive for HIV at Screening
Active Hepatitis B or C. In participants with a history of Hepatitis B or Hepatitis C infection, HBsAg and HCV RNA tests have to be negative
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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