Solid TumorsPhase 1NCT03861403
A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
A Phase 1 study testing TRX518, Cyclophosphamide and Avelumab in people with Solid Tumors and Advanced Triple Negative Breast Cancer, run by Leap Therapeutics, Inc. at 4 sites in United States.
Trial summary
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: Phase 1b Dose Escalation Part 1 (Doublet Therapy) Dose Escalation Part 2 (Triplet Therapy) Phase 2a Dose Expansion (Triplet Therapy) Approximately 125 adult patients with histologically confirmed advanced solid tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer
- What is being tested?
- TRX518, Cyclophosphamide and Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 May 2019to 14 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced Solid Malignancies in Dose Escalation Parts 1 and 2:
- Histologically documented metastatic or locally advanced, incurable solid malignancy.
- At least one prior line of systemic therapy for metastatic or locally advanced disease.
- Advanced Triple Negative Breast Cancer (Dose Expansion):
- Histologically proven invasive breast carcinoma with triple-negative receptor status.
- At least 1 but no more than 2 prior lines of chemotherapy for metastatic or locally advanced disease.
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- Advanced Hormone Receptor-Positive/Endocrine-Refractory Breast Cancer (Dose Expansion):
- Histologically proven invasive breast carcinoma with hormone receptor+, HER2- status.
- Only postmenopausal women are eligible. - Previously received at least 1 line of aromatase inhibitor ± cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor therapy. Prior combination therapies of AI or selective estrogen receptor degrader (SERD [fulvestrant]) ± CDK 4/6 inhibitor or AI plus everolimus will be permitted. Up to 1 prior line of systemic chemotherapy for metastatic disease is allowed.
- Advanced Metastatic Castration-Resistant Prostate Cancer (Dose Expansion):
- Histologically or cytologically confirmed prostate adenocarcinoma or poorly differentiated carcinoma of the prostate.
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If a patient is being treated with LHRH agonists, this therapy must have been initiated at least 4 weeks prior to treatment start and must be continued throughout the study.
- Patients must have received ≥1 androgen receptor (AR) signaling inhibitors and had disease progression RECIST v1.1 after no more than 1 prior chemotherapy for mCRPC.
- Advanced Platinum-Resistant Ovarian Cancer (Dose Expansion):
- Histologically or cytologically confirmed diagnosis of metastatic, advanced, or recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
- Platinum-resistant ovarian cancer defined as disease progression following a response within 180 days following the last administered dose of platinum therapy. Patients who have lack of response (SD) or disease progression while receiving the most recent platinum-based therapy are not eligible.
- Received up to 3 lines of systemic therapy for platinum-sensitive disease, with the most recent regimen platinum-containing, and no prior systemic therapy for platinum-resistant or refractory disease.
- General:
- Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
- One or more tumors measurable on radiographic imaging defined by RECIST 1.1.
- Adult patients ≥18 years of age.
- ECOG performance status (PS) score of 0 or 1.
- Life expectancy of at least 12 weeks.
- Disease-free of active second/secondary or prior malignancies for ≥2 years, with the exception of currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast.
- Acceptable liver, renal, hematologic and coagulation function.
Who cannot join
- Hematologic malignancies or multiple myeloma.
- For the Dose Expansion cohorts the following cancers are not permitted:
- Any of the following pure histologies of ovarian cancer: germ cell, sex cord stroma, carcinosarcoma, or sarcoma.
- Small cell or pure neuroendocrine prostate carcinoma that has not yet been treated with at least one line of platinum-based chemotherapy (prostate adenocarcinoma with immunohistochemical neuroendocrine differentiation but without histological small cell that is naïve to platinum-based chemotherapy will be allowed.)
- Inflammatory breast cancer.
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
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- Cardiac function:
- Known ejection fraction of <50% by gated radionuclide study (e.g., multi-gated acquisition scan);
- Fridericia-corrected QT interval (QTcF) >470 msec (female) or >450 msec (male), or history of congenital long QT syndrome;
- Any ECG abnormality, including pericarditis, that in the Investigator's opinion, would preclude safe participation in the study.
- Active, uncontrolled bacterial, viral, or fungal infections within 7 days of study entry requiring systemic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Known clinically important respiratory impairment.
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- History of interstitial lung disease.
- Clinically significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
- Known to be human immunodeficiency virus (HIV) positive or have hepatitis B surface antigen (HBSAg) or hepatitis C antibodies (HCAb) unless hepatitis C virus (HCV) RNA is undetected/negative.
- History of major organ transplant (i.e., heart, lungs, liver, and kidney).
- History of an allogeneic bone marrow transplant.
- History of an autologous bone marrow transplant within 90 days of study entry.
- Symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible, provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Radiation must have been completed at least 14 days prior to study entry. Screening of asymptomatic patients without a history of CNS metastases is not required.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Pregnant or nursing women.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22903
Cleveland Clinic
Cleveland, Ohio, 44195
Horizon Oncology Research
Lafayette, Indiana, 47905
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases:
- Phase 1b
- Dose Escalation Part 1 (Doublet Therapy)
- Dose Escalation Part 2 (Triplet Therapy)
- Phase 2a
- Dose Expansion (Triplet Therapy)
Approximately 125 adult patients with histologically confirmed advanced solid tumors requiring therapy will be enrolled in the study. It is expected that approximately 24 patients will be enrolled in up to 4 cohorts, 2 cohorts in Dose Escalation Part 1 and 2 cohorts in Dose Escalation Part 2, of up to 6 patients per cohort. Up to 98 additional patients will be enrolled in the Dose Expansion phase of the study to achieve 88 evaluable patients (i.e., received at least 1 dose of study drug(s) and have 1 evaluable post-baseline modified RECIST v1.1 tumor response assessment; for mCRPC, assessment of soft tissue response will be per modified RECIST v1.1 and bone progression assessment will be per PCWG3 guidelines or discontinued treatment due to death, toxicity, or clinical progression) over 4 independent expansion groups.In either phase (1b or 2a), patients discontinuing for reasons unrelated to study treatment toxicity prior to completion of Cycle (C) 1 may be replaced to achieve the number of required evaluable patients per cancer type following consultation with the Sponsor. Data from each cohort in the Dose Escalation phase will be evaluated independently for safety and dose limiting toxicities (DLTs) prior to dose escalation and again prior to the Dose Expansion phase.
- Conditions
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer, Advanced Platinum-Resistant Ovarian Cancer
- Being tested
- TRX518, Cyclophosphamide, Avelumab
- Keywords
- Metastatic, Stage III or IV, Recurrent, Refractory, Solid tumors, Breast cancer, Prostate cancer, Ovarian cancer
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Breast Neoplasms, Prostatic Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX518Drug
Administered by IV infusion
CyclophosphamideDrug
Administered by IV infusion
AvelumabDrug
Also called BAVENCIO®
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| All Solid Tumors | Experimental | Phase 1b, Part 1 Dose Escalation: TRX518 + CTX Combination (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Assigned dose of cyclophosphamide administered intravenously on C1D1 and may be re-administered on D1 of a subsequent cycle
Phase 1b, Part 2 Dose Escalation: TRX518 + CTX + avelumab in (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Fixed dose of avelumab administered intravenously on D2 and D16 per cycle
* Fixed dose of cyclophosphamide administered at the MTD from Part 1 intravenously on C1D1 and may be re-administered on D1 of a subsequent cycle Receives: Drug: TRX518; Drug: Cyclophosphamide; Drug: Avelumab |
| Advanced Triple Negative Breast Cancer | Experimental | Phase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Fixed dose of avelumab administered intravenously on D2 and D16 per cycle
* Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle Receives: Drug: TRX518; Drug: Cyclophosphamide; Drug: Avelumab |
| Advanced Hormone Receptor+/Endocrine Refractory Breast Cancer | Experimental | Phase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Fixed dose of avelumab administered intravenously on D2 and D16 per cycle
* Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle Receives: Drug: TRX518; Drug: Cyclophosphamide; Drug: Avelumab |
| Advanced Metastatic Castration-Resistant Prostate Cancer | Experimental | Phase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Fixed dose of avelumab administered intravenously on D2 and D16 per cycle
* Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle Receives: Drug: TRX518; Drug: Cyclophosphamide; Drug: Avelumab |
| Advanced Platinum-Resistant Ovarian Cancer | Experimental | Phase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle):
Subjects receive the following treatment:
* Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle
* Fixed dose of avelumab administered intravenously on D2 and D16 per cycle
* Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle Receives: Drug: TRX518; Drug: Cyclophosphamide; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of subjects with dose limiting toxicities which will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
Measured: Baseline through 30 days post last dose (5 months)
Phase 1b: Identify the recommended Phase 2 dose (RP2D) of CTX in combination with fixed doses of TRX518 ± avelumab
Measured: Baseline through end of Cycle 1 (Day 28)
Phase 2a: Efficacy in Breast and Ovarian Cancer Groups: objective response rate
To determine the objective response rate according to modified RECIST v1.1
Measured: Baseline to study completion (approximately 4 months)
Phase 2a: Efficacy in Prostate Cancer Group: objective response rate
To determine the objective response rate according to modified RECIST 1.1 and PCWG3 guidelines
Measured: Baseline to study completion (approximately 4 months)
Secondary outcomes (13)
To determine the objective disease control rate (ODCR) according to modified RECIST 1.1 in breast and ovarian cancer groups
Measured: Baseline to study completion (approximately 4 months)
To determine the objective disease control rate (ODCR) according to modified RECIST 1.1 and PCWG3 guidelines in prostate cancer group
Measured: Baseline to study completion (approximately 4 months)
To determine the duration of response according to modified RECIST 1.1 in breast and ovarian cancer groups
Measured: Baseline to study completion (approximately 4 months)
To determine the duration of response according to modified RECIST 1.1 and PCWG criteria in prostate cancer group
Measured: Baseline to study completion (approximately 4 months)
To determine the progression free survival according to RECIST 1.1 in breast and ovarian cancer groups
Measured: Baseline to study completion (approximately 4 months)
To determine the progression free survival according to RECIST 1.1 and PCWG3 criteria in prostate cancer group
Measured: Baseline to study completion (approximately 4 months)
To determine overall survival (OS) in all cancer groups
Measured: Baseline to study completion (approximately 4 months)
To determine the PSA response in prostate cancer group
Measured: Baseline to study completion (approximately 4 months)
Evaluate the effect of TRX518 in combination with cyclophosphamide and avelumab on lymphoid cell subset numbers and function
Measured: Various timepoints through study completion (approximately 4 months)
Time to peak concentration (Tmax)
Observations of the distribution, duration of effects and chemical changes of TRX518 and avelumab in the body and the effects and routes of the body's elimination of TRX518 and avelumab
Measured: Various timepoints through study completion (approximately 4 months)
TRX518 and avelumab peak concentration (Cmax)
Observations of the distribution, duration of effects and chemical changes of TRX518 and avelumab in the body and the effects and routes of the body's elimination of TRX518 and avelumab
Measured: Various timepoints through study completion (approximately 4 months)
Area under the curve (AUC)
Observations of the distribution, duration of effects and chemical changes of TRX518 and avelumab in the body and the effects and routes of the body's elimination of TRX518 and avelumab
Measured: Various timepoints through study completion (approximately 4 months)
Assess TRX518 and avelumab immunogenicity
Measured: Various timepoints through study completion (approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start20 May 2019
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: Product development discontinued unrelated to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leap Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861403
- Sponsor's protocol ID
- TRX518-004
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03861403
- Acronym / sponsor ID
- TRX518-004
- Conditions
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer, Advanced Platinum-Resistant Ovarian Cancer
- Keywords
- Metastatic, Stage III or IV, Recurrent, Refractory, Solid tumors, Breast cancer, Prostate cancer, Ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product development discontinued unrelated to safety.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Leap Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, Merck KGaA, Darmstadt, Germany
- Study start
- 20 May 2019 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases:
- Phase 1b
- Dose Escalation Part 1 (Doublet Therapy)
- Dose Escalation Part 2 (Triplet Therapy)
- Phase 2a
- Dose Expansion (Triplet Therapy)
Approximately 125 adult patients with histologically confirmed advanced solid tumors requiring therapy will be enrolled in the study. It is expected that approximately 24 patients will be enrolled in up to 4 cohorts, 2 cohorts in Dose Escalation Part 1 and 2 cohorts in Dose Escalation Part 2, of up to 6 patients per cohort. Up to 98 additional patients will be enrolled in the Dose Expansion phase of the study to achieve 88 evaluable patients (i.e., received at least 1 dose of study drug(s) and have 1 evaluable post-baseline modified RECIST v1.1 tumor response assessment; for mCRPC, assessment of soft tissue response will be per modified RECIST v1.1 and bone progression assessment will be per PCWG3 guidelines or discontinued treatment due to death, toxicity, or clinical progression) over 4 independent expansion groups.In either phase (1b or 2a), patients discontinuing for reasons unrelated to study treatment toxicity prior to completion of Cycle (C) 1 may be replaced to achieve the number of required evaluable patients per cancer type following consultation with the Sponsor. Data from each cohort in the Dose Escalation phase will be evaluated independently for safety and dose limiting toxicities (DLTs) prior to dose escalation and again prior to the Dose Expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| All Solid Tumors | Experimental | Drug: TRX518, Drug: Cyclophosphamide, Drug: AvelumabPhase 1b, Part 1 Dose Escalation: TRX518 + CTX Combination (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Assigned dose of cyclophosphamide administered intravenously on C1D1 and may be re-administered on D1 of a subsequent cycle Phase 1b, Part 2 Dose Escalation: TRX518 + CTX + avelumab in (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Fixed dose of avelumab administered intravenously on D2 and D16 per cycle * Fixed dose of cyclophosphamide administered at the MTD from Part 1 intravenously on C1D1 and may be re-administered on D1 of a subsequent cycle |
| Advanced Triple Negative Breast Cancer | Experimental | Drug: TRX518, Drug: Cyclophosphamide, Drug: AvelumabPhase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Fixed dose of avelumab administered intravenously on D2 and D16 per cycle * Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle |
| Advanced Hormone Receptor+/Endocrine Refractory Breast Cancer | Experimental | Drug: TRX518, Drug: Cyclophosphamide, Drug: AvelumabPhase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Fixed dose of avelumab administered intravenously on D2 and D16 per cycle * Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle |
| Advanced Metastatic Castration-Resistant Prostate Cancer | Experimental | Drug: TRX518, Drug: Cyclophosphamide, Drug: AvelumabPhase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Fixed dose of avelumab administered intravenously on D2 and D16 per cycle * Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle |
| Advanced Platinum-Resistant Ovarian Cancer | Experimental | Drug: TRX518, Drug: Cyclophosphamide, Drug: AvelumabPhase 2a Dose Expansion: TRX518 + CTX Combination + avelumab (28-Day Cycle): Subjects receive the following treatment: * Fixed dose of TRX518 administered intravenously on D2 and D16 per cycle * Fixed dose of avelumab administered intravenously on D2 and D16 per cycle * Fixed dose of cyclophosphamide identified in Phase 1b administered on C1D1 and may be re-administered on D1 of a subsequent cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Advanced Solid Malignancies in Dose Escalation Parts 1 and 2:
- Advanced Triple Negative Breast Cancer (Dose Expansion):
- Advanced Hormone Receptor-Positive/Endocrine-Refractory Breast Cancer (Dose Expansion):
- Advanced Metastatic Castration-Resistant Prostate Cancer (Dose Expansion):
- Advanced Platinum-Resistant Ovarian Cancer (Dose Expansion):
Key exclusion criteria (23 listed)
- Hematologic malignancies or multiple myeloma.
- For the Dose Expansion cohorts the following cancers are not permitted:
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
- Cardiac function:
- Active, uncontrolled bacterial, viral, or fungal infections within 7 days of study entry requiring systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX518Administered by IV infusion | Drug | Advanced Hormone Receptor+/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer, Advanced Platinum-Resistant Ovarian Cancer, Advanced Triple Negative Breast Cancer, All Solid Tumors |
| CyclophosphamideAdministered by IV infusion | Drug | Advanced Hormone Receptor+/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer, Advanced Platinum-Resistant Ovarian Cancer, Advanced Triple Negative Breast Cancer, All Solid Tumors |
| AvelumabAlso: BAVENCIO®Administered by IV infusion | Drug | Advanced Hormone Receptor+/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer, Advanced Platinum-Resistant Ovarian Cancer, Advanced Triple Negative Breast Cancer, All Solid Tumors |
Primary outcome
Phase 1b: Number of subjects with dose limiting toxicities which will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
Time frame: Baseline through 30 days post last dose (5 months)
Phase 1b: Identify the recommended Phase 2 dose (RP2D) of CTX in combination with fixed doses of TRX518 ± avelumab
Time frame: Baseline through end of Cycle 1 (Day 28)
Phase 2a: Efficacy in Breast and Ovarian Cancer Groups: objective response rate
Time frame: Baseline to study completion (approximately 4 months)
To determine the objective response rate according to modified RECIST v1.1
Phase 2a: Efficacy in Prostate Cancer Group: objective response rate
Time frame: Baseline to study completion (approximately 4 months)
To determine the objective response rate according to modified RECIST 1.1 and PCWG3 guidelines
13 secondary outcomes
To determine the objective disease control rate (ODCR) according to modified RECIST 1.1 in breast and ovarian cancer groups
Time frame: Baseline to study completion (approximately 4 months)
To determine the objective disease control rate (ODCR) according to modified RECIST 1.1 and PCWG3 guidelines in prostate cancer group
Time frame: Baseline to study completion (approximately 4 months)
To determine the duration of response according to modified RECIST 1.1 in breast and ovarian cancer groups
Time frame: Baseline to study completion (approximately 4 months)
To determine the duration of response according to modified RECIST 1.1 and PCWG criteria in prostate cancer group
Time frame: Baseline to study completion (approximately 4 months)
To determine the progression free survival according to RECIST 1.1 in breast and ovarian cancer groups
Time frame: Baseline to study completion (approximately 4 months)
To determine the progression free survival according to RECIST 1.1 and PCWG3 criteria in prostate cancer group
Time frame: Baseline to study completion (approximately 4 months)
To determine overall survival (OS) in all cancer groups
Time frame: Baseline to study completion (approximately 4 months)
To determine the PSA response in prostate cancer group
Time frame: Baseline to study completion (approximately 4 months)
Evaluate the effect of TRX518 in combination with cyclophosphamide and avelumab on lymphoid cell subset numbers and function
Time frame: Various timepoints through study completion (approximately 4 months)
Time to peak concentration (Tmax)
Time frame: Various timepoints through study completion (approximately 4 months)
TRX518 and avelumab peak concentration (Cmax)
Time frame: Various timepoints through study completion (approximately 4 months)
Area under the curve (AUC)
Time frame: Various timepoints through study completion (approximately 4 months)
Assess TRX518 and avelumab immunogenicity
Time frame: Various timepoints through study completion (approximately 4 months)
Results and safety
The study was stopped early (reason given: Product development discontinued unrelated to safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRX518, Cyclophosphamide and Avelumab in people with Solid Tumors and Advanced Triple Negative Breast Cancer, run by Leap Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Product development discontinued unrelated to safety.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of subjects with dose limiting toxicities which will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) (time frame: Baseline through 30 days post last dose (5 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.