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Sponsor Decision
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.
This is an open-label, multicenter, phase 1b dose-expansion study to evaluate the safety, tolerability, preliminary antitumor activity, PK, and pharmacodynamics of 2 dose levels of IK-175, administered PO in combination with nivolumab, in patients with primary PD-1-resistant metastatic or locally incurable, recurrent HNSCC for which standard therapy is no longer effective or is intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 600 mg qd PO IK-175 + nivolumab |
|
| Cohort 2 | Experimental | 450 mg q12h PO IK-175 + nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IK-175 + nivolumab | Drug | IK-175 + nivolumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment emergent adverse events (TEAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability] | Number and severity of TEAEs as assessed by CTCAE 5.0 | Treatment Period (Approximately 18 months) |
| Frequency and severity of treatment related adverse events (TRAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability] | Number and severity of TRAEs as assessed by CTCAE 5.0 | Treatment Period (Approximately 18 months) |
| Frequency and severity of serious adverse events (SAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability] | Number and severity of SAEs as assessed by CTCAE 5.0 | Treatment Period (Approximately 18 months) |
| Frequency and severity of adverse events leading to dose modifications and/or treatment discontinuation in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability] | Number and severity of adverse events leading to dose modifications and/or treatment discontinuation as assessed by CTCAE 5.0 | Study Treatment Period (Approximately 18 months) |
| Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Objective response rate (ORR) | ORR is defined as the percentage of participants with confirmed complete response (cCR) or confirmed partial response (cPR) per RECIST 1.1 | Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months) |
| Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Disease control rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of IK-175 when administered in combination with nivolumab: half-life (t1/2) | Determine IK-175 half-life (t1/2) | Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria are listed in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Kim, MD | Ikena Oncology | Study Director |
| Karim Malek, MD | Ikena Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| Washington University |
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Randomized 1:1 to Cohort 1 or Cohort 2
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Open label study
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DCR is defined as the percentage of participants with no occurrence of progressive disease with either cCR, cPR, or stable disease [SD] ≥ 16 weeks per RECIST 1.1 from the beginning of study therapy |
| Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months) |
| Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Duration of response (DOR) | DOR is defined as the time from the first documented CR or PR per RECIST 1.1 until disease progression or death from any cause | Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months)) |
| PK of IK-175 when administered in combination with nivolumab: area under the plasma concentration-time curve (AUC) |
Determine IK-175 AUC |
| Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months) |
| PK of IK-175 when administered in combination with nivolumab: maximum serum concentration (Cmax) | Determine IK-175 Cmax | Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months) |
| PK of IK-175 when administered in combination with nivolumab: minimum serum concentration (Cmin) | Determine IK-175 Cmin | Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months) |
| Preliminary antitumor activity of IK-175 in combination with nivolumab: Progression-free survival (PFS) median and at 6 months | PFS is defined as the length of time from the beginning of study treatment to the first observed disease progression or death due to any cause | Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months) |
| Preliminary antitumor activity of IK-175 in combination with nivolumab: Overall survival (OS), median and at 6 months | OS is defined as the length of time from the beginning of study treatment to the date of death due to any cause | Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 12 months) |
| St Louis |
| Missouri |
| 63130 |
| United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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