Results from a Phase 1b/2 study evaluating Nivolumab in combination with HBI-8000 for advanced solid tumors were posted on 2026-07-30. The trial demonstrated an Objective Response Rate (ORR) of 56.6% in patients with melanoma, with the 30 mg dose of HBI-8000 showing a favorable safety profile when combined with Nivolumab.

Background

Nivolumab is an established immunotherapy. This study explored its combination with HBI-8000 in patients with advanced Melanoma, Renal Cell Carcinoma (RCC), and Non-Small Cell Lung Cancer (NSCLC).

Trial design

The Phase 1b/2 study (NCT02718066) enrolled 96 patients with advanced Melanoma, Renal Cell Carcinoma, and Non-Small Cell Lung Cancer. The primary objective was to assess the safety and tolerability of HBI-8000 in combination with Nivolumab, including the frequency and severity of toxicities. Secondary objectives included exploring efficacy as measured by Objective Response Rate (ORR).

Key results

Safety analysis for dose-limiting toxicities (DLTs) showed that 0 patients experienced a DLT at the 20 mg dose of HBI-8000 in combination with Nivolumab, and 0 patients at the 30 mg dose. At the 40 mg dose, 2 patients experienced at least one DLT. The recommended Phase 2 dose (RP2D) was determined to be HBI-8000 30 mg.

Efficacy results at the RP2D demonstrated an Objective Response Rate (ORR) of 56.6% (95% Confidence Interval) in patients with Melanoma, 22.7% (95% Confidence Interval) in Non-Small Cell Lung Cancer (NSCLC) patients, and 16.7% (95% Confidence Interval) in Renal Cell Carcinoma (RCC) patients. The overall ORR across all patients treated at RP2D was 44.4% (95% Confidence Interval). The Disease Control Rate (DCR) was 84.9% (95% Confidence Interval) for Melanoma, 68.2% (95% Confidence Interval) for NSCLC, and 66.7% (95% Confidence Interval) for RCC, with a total DCR of 79.0% (95% Confidence Interval). Duration of Response (DoR) for melanoma patients was reported as NA (median, 95% Confidence Interval).

What this means

The results indicate that the combination of HBI-8000 at a 30 mg dose with Nivolumab is generally well-tolerated, with no DLTs observed at this dose level. The efficacy signals, particularly the 56.6% ORR and 84.9% DCR in advanced Melanoma, suggest a potential therapeutic benefit for this combination. These findings support continued development and further evaluation of this regimen in larger clinical trials for these advanced solid tumors.

Source

This information is based on trial results posted on ClinicalTrials.gov for study NCT02718066 on 2026-07-30. The full details are available on clinicaltrials.gov.