Advanced Solid TumorPhase 1/2NCT07602842
A Study of IDP-001 in Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing IDP-001 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by InduPro, Inc. at 6 sites in United States.
Trial summary
This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- IDP-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Jul 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
- Satisfy requirements for prior treatments per tumor type as outlined in the protocol
- Measurable disease per RECIST v1.1
- Participant willing to provide tumor biopsies
- Adequate organ function
- Agree to contraception requirements as outlined in the protocol
- Life expectancy greater than 12 weeks
Who cannot join
- Any clinically significant cardiac disease
- Any clinically significant corneal disorder
- Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
- Active significant neurologic disorders
- Requires home oxygen
- Active autoimmune disease
Show all 23Show fewer
- History or active skin disease requiring frequent treatment
- History of major immunologic reaction to prior immunoglobulin G-containing agent
- Clinically significant ascites or liver disease
- Uncontrolled diabetes or diabetic neuropathy
- Active bleeding disorders
- Participation in a concurrent clinical study in the treatment period
- Pregnant or lactating or planning to become pregnant
- Known hypersensitivity to IDP-001 or any of its ingredients
- Unresolved toxicities from previous anticancer therapy
- Has had a seizure prior to Screening
- Prior solid organ transplant or allogeneic stem cell transplant
- Current endocrinopathy
- History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
- History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids
- Stroke or transient ischemic attack prior to Screening
- Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
1-800-767-9355, AskRoswell@RoswellPark.org
Prantesh Jain, M.D.
- Recruiting
START Dallas Forth Worth
Fort Worth, Texas, 76104
hopeteam@startresearch.com
Salwan Al-Mutar, M.D.
- Recruiting
Community Cancer Center North
Indianapolis, Indiana, 46250
Adam Norris, 317-621-3858, anorris@ecommunity.com
Nikhil Shukla, M.D.
- Recruiting
START New York Long Island
Lake Success, New York, 11042
hopeteam@startresearch.com
Geraldine O'Sullivan-Coyne, M.D.
- Recruiting
START Los Angeles
Los Angeles, California, 90025
hopeteam@startresearch.com
Navid Hafez, M.D.
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
941-377-9993, clinicaltrials@flcancer.com
Manish Patel, M.D.
About this study
Official title: A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors
This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Head and Neck Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Cervix, Non Squamous Non Small Cell Lung Cancer
- Being tested
- IDP-001
- Keywords
- NSCLC, Squamous NSCLC
- Medical subject headings
- Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Anus Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-001Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Part 1 Dose Escalation | Experimental | Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion. Receives: Drug: IDP-001 |
| Phase 1 Part 2 Indication Selection | Experimental | Participants with a single tumor indication will receive IDP-001 as IV infusion Receives: Drug: IDP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
Measured: 3 weeks
Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Measured: Approximately 6 months
Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Secondary outcomes (10)
Area Under the Concentration Time Curve (AUC) of IDP-001
Measured: Approximately 6 months
Maximum Observed Plasma Concentration (Cmax) of IDP-001
Measured: Approximately 6 months
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Measured: Approximately 6 months
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Measured: Approximately 6 months
Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator
Measured: Approximately 6 months
Phase 1 Part 2: Overall Survival (OS)
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start8 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InduPro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602842
- Sponsor's protocol ID
- IDP-001-101
- Status last verified
- Jul 2026
- First submitted
- 8 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT07602842
- Acronym / sponsor ID
- IDP-001-101
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Head and Neck Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Cervix, Non Squamous Non Small Cell Lung Cancer
- Keywords
- NSCLC, Squamous NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- InduPro, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Part 1 Dose Escalation | Experimental | Drug: IDP-001Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion. |
| Phase 1 Part 2 Indication Selection | Experimental | Drug: IDP-001Participants with a single tumor indication will receive IDP-001 as IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
- Satisfy requirements for prior treatments per tumor type as outlined in the protocol
- Measurable disease per RECIST v1.1
- Participant willing to provide tumor biopsies
Key exclusion criteria (23 listed)
- Any clinically significant cardiac disease
- Any clinically significant corneal disorder
- Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
- Active significant neurologic disorders
- Requires home oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDP-001IV infusion | Drug | Phase 1 Part 1 Dose Escalation, Phase 1 Part 2 Indication Selection |
Primary outcome
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
Time frame: 3 weeks
Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Time frame: Approximately 6 months
Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
10 secondary outcomes
Area Under the Concentration Time Curve (AUC) of IDP-001
Time frame: Approximately 6 months
Maximum Observed Plasma Concentration (Cmax) of IDP-001
Time frame: Approximately 6 months
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Time frame: Approximately 6 months
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Time frame: Approximately 6 months
Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Overall Survival (OS)
Time frame: Approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDP-001 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by InduPro, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact InduPro Inc. (617-798-1770, clinicaltrials@induprotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.