Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (2)

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
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
Through study completion, up to 2,5 years

Secondary Outcomes (3)

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

Study Arms (3)

Monotherapy dose escalation, IV, Q3W, multiple dose levels

EXPERIMENTAL

ADU-1805 monotherapy dose escalation

Drug: ADU-1805

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

EXPERIMENTAL

ADU-1805 plus pembrolizumab dose escalation

Drug: ADU-1805Drug: Pembrolizumab

Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

EXPERIMENTAL

Interventions

ADU-1805Drug

anti-SIRPα monoclonal antibody

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed doseCombination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed doseMonotherapy dose escalation, IV, Q3W, multiple dose levels

PembrolizumabDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female aged ≥18 years
Signed and dated informed consent form

Sponsors & Collaborators

Sairopa B.V.
Industrylead

Study Sites (11)

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

RECRUITING

Weise, Dr.CONTACT

Washington University Medical Campus

St Louis, Missouri, 63110, United States

RECRUITING

Khushman, Dr.CONTACT

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasmsColorectal NeoplasmsCarcinoma, Renal CellCarcinoma, Non-Small-Cell LungEndometrial Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Central Study Contacts

Sairopa Clinical Team

CONTACT

0031 85 90 26 939 clinical@sairopa.com

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

January 4, 2023

First Posted

May 12, 2023

Study Start

April 3, 2023

Actual (reported)

Primary Completion

May 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Monotherapy dose escalation, IV, Q3W, multiple dose levels

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Monotherapy dose escalation, IV, Q3W, multiple dose levels

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source records

Locations