AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

NCT07454642 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALS-6103-101
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief Summary

This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.

Conditions

Cervical Adenosquamous Carcinoma; Small Cell Carcinoma of Lung; Vulvar Adenocarcinoma; Gastric Adenocarcinoma; Cervical Adenocarcinoma; GEJ Adenocarcinoma; PDAC - Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Hormone Receptor Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).

  From Day 1 until up to 30 days after last dose of study drug.

• Dose-limiting toxicities (DLTs)

  Incidence and nature of DLTs

  21 days from the first dose for the every 3 week dosing schedule and 28 days from the first dose for the every 2 week schedule

Secondary Outcomes (8)

• Objective response rate (ORR)

  From Day 1 until up to 30 days after last dose of study drug.

• Duration of Response (DoR)

  From Day 1 until up to 30 days after last dose of study drug.

• Progression-free-survival (PFS)

  From Day 1 until up to 30 days after last dose of study drug.

• Overall survival (OS)

  Up to one year after last dose of study drug.

• Maximum plasma concentration

  Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.

Study Arms (3)

AVA6103 Phase 1a Dose Escalation Q3W

EXPERIMENTAL

Patients in this arm will receive escalating doses of AVA6103 Q3W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.

Drug: AVA6103

AVA6103 Phase 1a Dose Escalation Q2W

EXPERIMENTAL

Patients in this arm will receive escalating doses of AVA6103 Q2W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.

Drug: AVA6103

AVA6103 Phase 1b Dose Expansion

EXPERIMENTAL

Patients in this arm will receive AVA6103 at the recommended phase 2 dose, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first.

Drug: AVA6103

Interventions

AVA6103 DRUG

AVA6103 is a FAP-activated Exatecan

AVA6103 Phase 1a Dose Escalation Q2W; AVA6103 Phase 1a Dose Escalation Q3W; AVA6103 Phase 1b Dose Expansion

Eligibility Criteria

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

You may qualify if:

• The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
• Male or female subjects, ≥18 years of age.
• Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments
• Cervical/vulvar cancer
• SCLC
• Gastric/GEJ cancer
• PDAC
• CRC
• HR+ breast cancer
• Has a life expectancy of ≥3 months, in the opinion of the investigator.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).
• Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):
• Absolute neutrophil count of ≥1.5 × 109 cells/L. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells/L
• Hemoglobin ≥9.0 g/dL.

You may not qualify if:

• Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg/day or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.
• Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.
• Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
• History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
• History of known infection is defined as:
• HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \>400 copies/mL prior to study Day 1.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).
• Subjects with active disease who are not on/have not initiated anti-retroviral treatment prior to study Day 1.
• Subjects with untreated HCV infection or have not completed treatment for HCV infection.
• Subjects with treated HCV infection but with an HCV viral load above the level of quantification.
• Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.
• Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.
• Is a pregnant or breastfeeding woman.

Sponsors & Collaborators

• Avacta Life Sciences Ltd: lead

Study Sites (3)

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NEXT Oncology

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Avacta Clinical Team

CONTACT

+44 (0)20 3911 0353; clinicaltrials@avacta.com

Study Design

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

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)