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IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

ConditionsAdvanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Malignant Solid NeoplasmAdvanced MelanomaAdvanced Ovarian Clear Cell AdenocarcinomaChondrosarcomaClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Recurrent Ovarian High Grade Serous AdenocarcinomaRefractory Endometrial CarcinomaRefractory Head and Neck Squamous Cell CarcinomaRefractory MelanomaRefractory Ovarian Clear Cell AdenocarcinomaRefractory Ovarian High Grade Serous AdenocarcinomaStage III Ovarian Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.

Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing therapy(ies) known to provide clinical benefit for their condition.

Prior treatment with chemotherapy, radiotherapy, immunotherapy or any investigational therapies must have been completed at least 3 weeks or at least five half lives, whichever is shorter, before the study drug administration, and all AEs (excluding alopecia and peripheral neuropathy) have either returned to ≤Grade 1 or stabilized. Patients with concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) are allowed.

Disqualifiers

Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.

Known primary central malignancy or symptomatic central nervous system metastasis(es).

Any unstable cardiac arrhythmia within 6 months prior to enrolment

Prolongation of the Fridericia corrected QT (QTcF) interval defined as >450 ms for males and >470 ms for females

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Biological/Vaccine

    Given IV

  • Glutaminase-1 Inhibitor IACS-6274

    Drug

    Given by PO

  • Paclitaxel

    Drug

    Given by IV (vein)

  • Capivasertib

    Drug

    Given by PO

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Part A (IACS-6274)Experimental treatment 1 intervention
Group B: Part B (IACS-6274, bevacizumab, paclitaxel)Experimental treatment 3 interventions
Group C: PART C: (IACS-6274) with capivasertibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Will be assessed by the rate of dose limiting toxicities at each dose level in the dose escalation, and the rate of AEs and the rate of Grade 3 and higher AEs in the dose escalation and dose expansion. All AEs will be coded according to the latest version of Medical Dictionary for Regulatory Activities and National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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