KGX101 / KangaBio - LARVOL DELTA

This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY | Trial completion date: May 2026 ➔ May 2028

First-in-human • Monotherapy • Trial completion date • Melanoma • Oncology • Solid Tumor • IL12A • PD-L1

First-in-human study of the IL-12 Prodrug KGX101 demonstrates tumor-microenvironment specific activation, promising antitumor activity, and a manageable safety profile in advanced or metastatic melanoma (AACR 2026) - "KGX101 demonstrates a manageable safety profile, promising preliminary efficacy, and evidence of robust immune activation in patients with advanced solid tumors. These supportive data warrant continued clinical development of KGX101."

Biomarker • Clinical • First-in-human • IO biomarker • Metastases • P1 data • Tumor microenvironment • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL12A • PD-1

In vitro masked effect, in vivo anti-tumor activity and toxicology study of KGX101, an interleukin-12 prodrug, in monotherapy or in combination with anti-PD-L1 antibody (AACR 2024) - "In a 4-week repeat dose toxicity study in Cynomolgus monkeys, the highest non-severely toxic dose (HNSTD) of KGX101 was determined to be 0.1 mg/kg. The results from nonclinical toxicology studies support the potential of KGX101 as a well-tolerated therapy for the First-in-Human (FIH) clinical trial."

Combination therapy • First-in-human • Monotherapy • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • IFNG • IL12A

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov) - P1 | N=57 | Recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY

Monotherapy • New P1 trial • Solid Tumor • IL12A

This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy with Envafolimab in Patients with Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Oncology • Solid Tumor

This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY | Not yet recruiting ➔ Recruiting | N=27 ➔ 54 | Trial completion date: Sep 2026 ➔ May 2026 | Trial primary completion date: Jan 2026 ➔ May 2026

Combination therapy • Enrollment change • Enrollment open • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Sanyou Bio Congratulates KangaBio on their IND Approval for Next-Generation IL-12 Prodrug Cancer Immunotherapy (PRNewswire) - "On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The KGX101 clinical trials will be carried out simultaneously in both United States and Australia. These trials will primarily focus on late-stage solid tumors and the effectiveness will either be evaluated as a standalone therapy or in combination with anti-PD-L1 antibodies. Several research centers in Australia have already commenced patient screening for participation in these clinical trials."

IND • Trial status • Solid Tumor

A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Kangabio AUSTRALIA LTD PTY

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor