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.

NCT06074497 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KGX101ST101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open label, two-part, multicenter, multi-regional 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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Number of participants with Treatment emergent Adverse events (TEAEs)

  TEAE will be collected to assess participants' safety after KGX101 treatment.

  From baseline to 30 days after the last dose administration.

• Number of participants with Dose Limiting Toxicities (DLTs) at week 4

  DLT will be observed from start of treatment until 21 days post the first target dose treatment.

  From Day 1 after the first dose of KGX101 full treatment to D21 post dose.

• Number of participants with changes to clinical laboratory abnormalities

  Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated.

  Screening to 90 days post last dose administration

• To estimate the Maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab.

  From Day 1 after the first dose of KGX101 full treatment to D21 post dose.

Secondary Outcomes (13)

• PK Parameters: Maximum Concentration (Cmax)

  Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

• PK Parameters: Time of maximum observed concentration (Tmax)

  Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

• PK Parameters: Area under the curve (AUC)

  Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

• PK Parameters: Half- life (T1 /2)

  Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

• PK Parameters- Trough concentration (Ctrough)

  Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

Study Arms (7)

KGX101- Cohort -1

EXPERIMENTAL

Dosage level: Dose level 1 Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort -1

KGX101- Cohort 1

EXPERIMENTAL

Dosage level: Dose level 2. Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort 1

KGX101- Cohort 2

EXPERIMENTAL

Dosage level: Dose level 3 Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort 2

KGX101- Cohort 3

EXPERIMENTAL

Dosage level: Dose level 4 Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort 3

KGX101- Cohort 4

EXPERIMENTAL

Dosage level: Dose level 5 Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort 4

KGX101- Cohort 5

EXPERIMENTAL

Dosage level: Dose level 6 Dose form: White-like lyophilized powder Route of administration: Intravenous

Drug: KGX101- Cohort 5

KGX101 and Envafolimab

ACTIVE COMPARATOR

Part B combination therapy KGX101 with Envafolibmab. Dose form: Injection Route to administration: Injection

Drug: KGX101 and Envafolimab

Interventions

KGX101- Cohort 1 DRUG

Single dose of 0.3, 1.0, 3.0μg/kg of KGX101 every 3 weeks

KGX101- Cohort 1

KGX101- Cohort 2 DRUG

Single dose of 1, 1 and 3μg/kg of KGX101 every 3 weeks

KGX101- Cohort 2

KGX101- Cohort 3 DRUG

Single dose of 1,3 and 6μg/kg of KGX101 every 3 weeks

KGX101- Cohort 3

KGX101- Cohort 4 DRUG

Single dose of 1,3,12μg/kg of KGX101 every 3 weeks

KGX101- Cohort 4

KGX101- Cohort 5 DRUG

Single dose of 2, 5 and 15 μg/kg of KGX101 every 3 weeks

KGX101- Cohort 5

KGX101 and Envafolimab DRUG

Part B combination therapy KGX101 with Envafolibmab. 400mg to be injected subcutaneously with each target dose of KGX101 every 3 weeks. The dose escalation committee (DEC) may decide to increase the dosage to 600mg. based on PK, PD and safety data.

KGX101 and Envafolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or for which no further standard therapy exists.
• Part B- In addition to above for Part B, participants should be tumor PD-L1 expression negative or with PD-L1 expression too low to fit for the immune checkpoint inhibitor treatment or have had disease progression after immune checkpoint inhibitor treatment.
• Age at least 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.
• Has at least 1 measurable lesion per RECIST 1.1 (lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions).
• Has adequate organ and bone marrow function as per the study (blood transfusion or use of use hematopoietic stimulating factor for correction within 14 days are not permitted):
• Hematologic: White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L; a hemoglobin level \> 90 g/L; and a platelet count ≥ 100 x 109/L;
• Adequate hepatic function as defined by:
• Total bilirubin ≤ 1.5 times the ULN if no liver metastases or ≤ 2.5 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases;
• Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline phosphatase (ALP) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases;
• Coagulation international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x the ULN;
• Adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN concurrent with creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-- Gault equation);
• Biochemistry: albumin ≥ 3.0g/dL
• Willingness of men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 5 months following the last dose of study drug.
• Paired pre-treatment archival tumor tissue within two years or fresh tumor biopsy and on-treatment fresh tumor biopsy will be optional. For participants of cutaneous malignant melanoma, paired pre-treatment archival tumor tissue and on-treatment fresh tumor biopsy should be mandatory

You may not qualify if:

• Active known second malignancy with the exception of any of the following: adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer, breast cancer, papillary thyroid carcinoma; adequately treated stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years; low risk prostate cancer with Gleason score \< 7 and prostate-specific antigen \<10ng/mL; any other cancer from which the patient has been disease-free survival for ≥ 5 years.
• Patients with primary CNS malignancies.
• A history of allogeneic tissue/solid organ transplant.
• Any evidence of severe or uncontrolled systemic diseases, including:
• Active, uncontrolled systemic bacterial, viral, or fungal infection;
• uncontrolled hypertension (Systolic blood pressure more than equal to 160mHG or diastolic blod pressure more than equal to 100mm HG or poor compliance with anti-hypertensive agents;
• or active bleeding diatheses;
• Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association \[NYHA\]) or acute myocardial infarction within 6 months;
• Uncontrolled diabetes or poor compliance with hypoglycemic agents;
• The presence of chronically unhealed wound or ulcers;
• Other chronic diseases, which, in the opinion of the Investigator, could compromise safety of the patient or the integrity of study.
• Active autoimmune disease requiring systemic treatment in the past 2 years.
• Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy.
• A history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
• HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.

Sponsors & Collaborators

• Kangabio AUSTRALIA LTD PTY: lead

Study Sites (3)

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

Location

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

MeSH Terms

Interventions

envafolimab

Study Officials

• Weidong Jiang, Dr

  Chief Executive Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: December 13, 2023
• Primary Completion: May 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)