Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

ConditionsSolid Tumor, Adult Metastatic Solid Tumor Refractory Cancer CRC, Colorectal Cancer RCC, Clear Cell Adenocarcinoma NSCLC (Advanced Non-small Cell Lung Cancer)Endometrial Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorSairopa B.V.

About this trial

This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥18 years

Signed and dated informed consent form

Measurable disease according to RECIST (Safety Expansion only)

ECOG Performance status of 0 or 1

Disqualifiers

Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)

> 3 lines of prior systemic treatments

MSS colorectal cancer (CRC): liver metastasis present

Pregnancy or breast-feeding

Trial design

Design model

Sequential

Treatments tested in this trial

ADU-1805
Drug
anti-SIRPα monoclonal antibody
Pembrolizumab
Drug
Keytruda

Treatment groups

130 Participants

are divided into 3 treatment groups

Group A: Monotherapy dose escalation, IV, Q3W, multiple dose levelsExperimental treatment 1 intervention

Group B: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed doseExperimental treatment 2 interventions

Group C: Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed doseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters

Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0

Time frame

First 21 days of treatment

Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.

Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame

Through study completion, up to 2,5 years

Secondary outcomes

Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters

Serum concentration-time profiles and PK parameters (including Cmax, AUC)

Time frame

Through study completion, up to 2,5 years

Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

Incidence of anti-ADU-antibodies

Time frame

Through study completion, up to 2,5 years

Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion

Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters.

Time frame

Through study completion, up to 2,5 years

Other outcomes

Escalation and Expansion Phase: Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

Investigate the mechanism of action and pharmacodynamics (PD) of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab using tumor tissue and blood biomarkers (e.g. immune monitoring)

Time frame

Through end of treatment, up to 2 years

Escalation and Expansion Phase: Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

Overall and duration of response per (i)RECIST, PFS, (duration) of disease control, OS

Time frame

Through study completion, up to 2,5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sairopa B.V.

Lead sponsor

Source ClinicalTrials.gov

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