OncoMatch/Clinical Trials/NCT05627960
First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
Is NCT05627960 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AG-01 Compound for triple negative breast cancer.
Treatment: AG-01 Compound — This is a first in human phase 1 study of AG01 an anti-Progranulin/Glycoprotein88 (PGRN/GP88) antibody in patients with advanced solid tumors. AG01 is a recombinant monoclonal antibody expressed in a CHO production cell line. The antibody AG01 binds to human PGRN/GP88, expressed on cancer cells. This study will have a dose escalation portion (1A) to evaluate maximum tolerated dose (MTD) and/or maximum administered dose (MAD), the safety and tolerability of AG01treatment before the dose expansion portion (1B) of the study is initiated. The dose escalation portion of this study (1A) will also be used to determine the recommended phase 2 dose (RP2D) of AG01 antibody to be evaluated in the cohort expansion portion (1B).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Small Cell Lung Cancer
Mesothelioma
Biomarker criteria
Required: GP88 expression 1+, 2+, or 3+ by IHC (1+, 2+, or 3+ by IHC)
patients must have GP88 tissue tumor tissue expression of 1+, 2+ or 3+ by IHC (phase 1B)
Allowed: PDCD1 PD(L)1-positive
If PD(L)1-positive, must have received a combination of chemotherapy and a PD (L)-1 agent (Atezolizumab or Pembrolizumab), unless not a candidate for these therapies
Allowed: BRCA1 germline mutation
If gBRCA 1 or 2 mutation is present, must have received SOC therapies including a PARPi, unless not a candidate for these therapies
Allowed: BRCA2 germline mutation
If gBRCA 1 or 2 mutation is present, must have received SOC therapies including a PARPi, unless not a candidate for these therapies
Allowed: PIK3CA mutation
If the tumor has known PIK3CA mutation, HT/Alpelisib combination should be considered unless not a candidate for this therapy
Allowed: EGFR sensitizing mutation
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: ALK rearrangement
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: ROS1 rearrangement
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: RET rearrangement
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: MET exon 14 skipping
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: BRAF V600E
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: KRAS G12C
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: NTRK1 fusion
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: NTRK2 fusion
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Allowed: NTRK3 fusion
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy or targeted therapy
Patients with relapsed/refractory solid tumor malignancies who failed one or more standard chemotherapy or targeted therapy regimens per SOC guidelines such as NCCN guidelines and for whom no standard therapy exists (Phase 1A)
Must have received: chemotherapy and PD-(L)1 agent (Atezolizumab, Pembrolizumab) — metastatic TNBC
If PD(L)1-positive, must have received a combination of chemotherapy and a PD (L)-1 agent (Atezolizumab or Pembrolizumab), unless not a candidate for these therapies
Must have received: PARP inhibitor — metastatic TNBC with gBRCA1/2 mutation
If gBRCA 1 or 2 mutation is present, must have received SOC therapies including a PARPi, unless not a candidate for these therapies
Must have received: hormonal therapy — hormone-resistant breast cancer
hormone-resistant breast cancer who received 1 or more hormonal (HT) therapies
Must have received: CDK4/6 inhibitor — hormone-resistant breast cancer
HT/CD4/6 kinase inhibitor
Must have received: mTOR inhibitor — hormone-resistant breast cancer
HT/MTOR inhibitor
Must have received: HT/Alpelisib combination (Alpelisib) — hormone-resistant breast cancer with PIK3CA mutation
If the tumor has known PIK3CA mutation, HT/Alpelisib combination should be considered unless not a candidate for this therapy
Must have received: platinum-based chemotherapy — NSCLC
failed 2 or more SOC therapies, including platinum-based chemotherapy and an anti-PD (L) -1 agent (sequentially or consecutively)
Must have received: anti-PD-(L)1 therapy — NSCLC
failed 2 or more SOC therapies, including platinum-based chemotherapy and an anti-PD (L) -1 agent (sequentially or consecutively)
Must have received: targeted therapy — NSCLC with sensitizing mutations/alterations/rearrangements
Patients with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies
Must have received: chemotherapy — mesothelioma
Mesothelioma patients who have received at least 1 SOC therapy for metastatic/recurrent mesothelioma per NCCN recommendations or not a candidate for SOC therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,000/uL; Platelets ≥ 100,000/µL
Kidney function
Creatinine ≤1.2 mg/dL; Clearance ≥50ml/min (Cockcroft-Gault)
Liver function
Total bilirubin WNL per Institution ULN; AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN
Adequate hepatic, renal, and bone marrow function: Absolute neutrophil count ≥ 1,000/uL Platelets ≥ 100,000/µL Total bilirubin WNL per Institution ULN AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN Creatinine ≤1.2 mg/dL Clearance ≥50ml/min (Cockcroft-Gault)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, Maryland
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