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A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

ConditionsAdvanced CancerAdvanced Solid TumorMelanomaMetastasisPleural MesotheliomaRenal Cell CarcinomaMSI-HighMismatch Repair DeficiencyColorectal CancerHepatocellular CarcinomaHepatocellular CancerRenal Cell CancerKidney CancerSkin CancerNon Small Cell Lung CancerNSCLCAnaplastic Lymphoma Kinase Genomic Tumor AberrationsALK Genomic Tumor Aberrations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor7 Hills Pharma, LLC

About this trial

This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.

Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Adult patients (age 18 or older)

Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1/PD-L1.

ANC ≥ 1000/µL without use of G-CSF, Hgb ≥ 9 g/dL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000/µL without transfusions for at least 5 days prior to pretreatment baseline.

ECOG performance status of 0 or 1.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Alintegimod

    Drug

    Alintegimod will be provided in bottles of 30 softgel capsules for oral administration

  • Ipilimumab

    Drug

    Ipilimumab (Yervoy) will be administered via IV

  • Nivolumab

    Drug

    Nivolumab (Opdivo) will be administered via IV

Treatment groups

126 Participants
are divided into 1 treatment group
Group A: Dose Escalation - Open Label Phase 1bExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0

To evaluate the safety and tolerability of Alintegimod administered as monotherapy, in the patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary

Time frame
1 year
2

Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0

To evaluate the safety and tolerability of Alintegimod administered in combination with ipilimumab followed by sequential nivolumab monotherapy, in the number of patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary

Time frame
1 year
3

Define RPTDs for Alintegimod

To define two doses of the Alintegimod + ipilimumab followed by nivolumab cohorts that will be used in the Phase 2a (Part B) study.

Time frame
18 months

Secondary outcomes

1

Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax)

To characterize the pharmacokinetics of Cmax of Alintegimod monotherapy.

Time frame
1 year
2

Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC)

To characterize the pharmacokinetics of AUC of Alintegimod monotherapy.

Time frame
1 year
3

Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax)

To characterize the pharmacokinetics of Cmax of Alintegimod in combination with ipilimumab.

Time frame
1 year
4

Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC)

To characterize the pharmacokinetics of AUC of Alintegimod in combination with ipilimumab.

Time frame
1 year

Other outcomes

Sponsors and contacts

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

7 Hills Pharma, LLC

Lead sponsor

Source ClinicalTrials.gov
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