What question did this study set out to answer?

This study investigates the safety and preliminary efficacy of TQB6411 in patients with advanced solid tumors.

May 29, 2026

First-in-human phase 1 study of TQB6411, an EGFR/c-Met bispecific antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Key Points

This study investigates the safety and preliminary efficacy of TQB6411 in patients with advanced solid tumors.
Patients with advanced malignant tumors intolerant to standard treatment were treated with TQB6411 every 3 weeks.
A combined accelerated titration and conventional 3+3 dose escalation design was implemented, starting at 0.8 mg/kg.
The primary endpoints included dose-limiting toxicity, recommended phase II dose, and safety.
26 patients were enrolled, with a median treatment duration of 3 cycles and no dose-limiting toxicities reported.
86.4% experienced at least one treatment-related adverse event, with common events being asthenia (54.5%) and infusion reactions (50.0%).
In the ≥4 mg/kg dose group, 50% had a partial response, indicating promising early efficacy.

Abstract

3032 Background: EGFR and c-Met overexpression are common across various solid tumors. TQB6411 is a novel ADC binding to both EGFR and c-Met with a valency of 1:2 to enhance the affinity to c-Met. Here we report the preliminary results of this first-in-human phase 1 study of TQB6411(NCT07043751). Methods: Patients (pts) with advanced malignant tumor who had failed or were intolerant to standard treatment were eligible. TQB6411 was administered intravenously once every 3 weeks. An accelerated titration design was used for the initial dose level (0.8 mg/kg), followed by a conventional 3+3 dose escalation design for the remaining dose levels. The primary endpoints were dose-limiting toxicity (DLT), recommended phase II dose and safety. Results: As of December 31, 2025, 26 pts were enrolled and received research treatment (median age range, 6033–75 years; 46.2% female). The most common diagnosis was non-small cell lung cancer (NSCLC, 21 pts), followed by esophageal cancer (EC, 3 pts) and colorectal cancer (CC, 2 pts). All pts had received at least one previous line of systemic treatment. Dose group assignments were as follows: 1 in 0.8mg/kg, 3 in 2.4mg/kg, 13 in 4mg/kg, 6 in 5.3mg/kg, and 3 in 6.6mg/kg. By the data cutoff date of January 9, 2026, the dose had been escalated to 6.6mg/kg, with no DLT occurring. The median treatment duration was 3 cycles (rang:1-9). In 22 pts who were followed up for at least 21 days, 19 (86.4%) experienced at least 1 treatment-related adverse event (TRAE). The most common TRAEs included asthenia (54.5%), infusion reaction (50.0%, decreasing to 38.9% in the ≥4 mg/kg dose group after prophylaxis modification), myalgia (27.3%), alopecia (22.7%), and neutrophil count decreased (22.7%). No interstitial lung disease occurred. Only 4 cases of grade 3 AEs (two of neutrophil count decreased, one of allergic shock, one of white blood cell count decreased) were observed in 3 pts and were all attributed to TQB6411. No ≥ grade 4 AEs occurred. In the ≥4 mg/kg dose group, 8 pts received at least one imaging assessment, 4 achieved a partial response (PR), giving an objective response rate of 50.0%. The disease control rate was 100%. The details of efficacy results are shown in the table below. Conclusions: In this ongoing phase 1 study. TQB6411 showed an impressive safety profile, with a lower incidence of higher-grade TRAEs (especially lower haematological toxicities), and encouraging efficacy, with tumor responses could be observed even in the relatively lower dose group. Clinical trial information: NCT07043751 . 4mg/kg (N = 6) 5.3mg/kg (N=2) PR, n 3 (NSCLC: 2, EC:1) 1(NSCLC) SD, n 3 (NSCLC) 1 (NSCLC)

Ask AI

Helpful

Bookmark