CancerPhase 1/2NCT03123783
CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
A Phase 1/2 study testing APX005M and Nivolumab in people with Cancer and Non Small Cell Lung Cancer Metastatic, run by Apexigen America, Inc. at 23 sites in 2 countries.
Trial summary
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma
- What is being tested?
- APX005M and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 10 Jul 2017to 16 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1 pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naive or could have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the appropriate therapy and progressed
- Histologically or cytologically confirmed unresectable or metastatic melanoma that progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD>=4 weeks later. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
- Measurable disease by RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver and kidney function
- Negative pregnancy test for women of child bearing potential
- Agreement to use effective methods of contraception per the protocol requirements
Who cannot join
- Previous exposure to any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1, anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of patients that must have previous treatment with anti-PD-1/PD-L1 therapy
- Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured
- Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
- Use of systemic corticosteroids or other systemic immunosuppressive drugs
- Active, known or suspected autoimmune disease
- History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
- History of interstitial lung disease
- History of life-threatening toxicity related to prior anti-PD-1/PD-L1 treatment for subjects with metastatic melanoma or NSCLC.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States13 sites
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)
Baltimore, Maryland, 21201
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
City of Hope
Duarte, California, 91010
Tennessee Oncology
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06520
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie, Florida, 32952
Fox Chase Center
Rockledge, Pennsylvania, 19046
SUNY Upstate Medical Hospital
Syracuse, New York, 13210
University of Arizona Cancer Center
Tucson, Arizona, 85724
Spain10 sites
Hospital Quirón Dexeus
Barcelona, 08028
H. Vall d'Hebron
Barcelona, 08035
H. Clinic i Provincial
Barcelona, 08036
H. Insular de Gran Canaria
Las Palmas de Gran Canaria
H. Lucus Augusti
Lugo, 27003
H. Doce de Octubre
Madrid, 28041
H. HM Sanchinnarro
Madrid, 28050
H. de Málaga
Málaga, 29010
H. La Fe
Valencia, 46014
H. General de Valencia
Valencia de Alcántara, 46014
About this study
Official title: A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Read the detailed description
APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase 1) followed by a Phase 2 tumor specific portion.
Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death, whichever occurs first.
Study objectives include:
- Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab
- Evaluate safety of the APX005M and nivolumab combination
- Evaluate the objective response rate, duration of response and median PFS by RECIST 1.1 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab
- Determine the PK of APX005M
- Conditions
- Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma, Neoplasm of Lung, Melanoma
- Being tested
- APX005M, Nivolumab
- Keywords
- CD40, Immunotherapy, Nivolumab, APX005M, PD-1
- Medical subject headings
- Neoplasms, Melanoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX005MDrug
APX005M is a CD40 agonistic monoclonal antibody
NivolumabDrug
Also called Opdivo
Nivolumab is an immune checkpoint (PD-1) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b escalation 0.03 mg/kg | Experimental | Non-small cell lung cancer (NSCLC) or metastatic melanoma
APX005M 0.03 mg/kg and nivolumab 360 mg every 3 weeks Receives: Drug: APX005M; Drug: Nivolumab |
| Phase 1b escalation 0.1 mg/kg | Experimental | Non-small cell lung cancer (NSCLC) or metastatic melanoma
APX005M 0.1 mg/kg and nivolumab 360 mg every 3 weeks Receives: Drug: APX005M; Drug: Nivolumab |
| Phase 1b escalation 0.3 mg/kg | Experimental | Non-small cell lung cancer (NSCLC) or metastatic melanoma
APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks Receives: Drug: APX005M; Drug: Nivolumab |
| Phase 2 expansion Cohort 1 | Experimental | Immunotherapy naïve, metastatic or locally advanced NSCLC
APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks Receives: Drug: APX005M; Drug: Nivolumab |
| Phase 2 expansion Cohort 2 | Experimental | Metastatic melanoma progressing during treatment with anti-PD-1/PD-L1 therapy
APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks Receives: Drug: APX005M; Drug: Nivolumab |
| Phase 2 expansion Cohort 3 | Experimental | Metastatic or locally advanced NSCLC progressing during treatment with anti-PD-1/PD-L1:
* Group A: best response of progressive disease or with stable disease < 16 weeks
* Group B: tumor response or with stable disease ≥ 16 weeks Receives: Drug: APX005M; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
All toxicities were graded according to the NCI-CTCAE version 4.03. DLT was defined as any of the following events attributed to APX005M and nivolumab combination:
- Grade 4 hematologic toxicity lasting ≥ 7 days (except asymptomatic lymphopenia)
- Grade 3 or 4 neutropenia with a single temperature of >38.3◦ C (101◦ F) or a sustained temperature of ≥38◦ C (100.4◦ F) for more than one hour
- Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia with signs or symptoms of bleeding or requiring platelet transfusion
- Grade 4 non-hematologic toxicity
- Grade 3 non-hematologic toxicity lasting >3 days despite optimal supportive care
- Any Grade ≥ 3 non-hematologic laboratory value if: medical intervention is required to treat the subject, abnormality leads to hospitalization, or abnormality persists for >1 week
- Failure to recover from a treatment-related AE to baseline or ≤ Grade 1 within 12 weeks of last dose of investigational product
- Grade 5 toxicity.
Measured: Up to 21 days following first dose of APX005M and nivolumab
Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b)
Establish the MTD dose of APX005M combined with 360 mg of nivolumab for which for which < 33% of DLT- evaluable participants experience a DLT. In Phase 1b, the RP2D was based on the overall safety and tolerability of the combination of APX005M and nivolumab by testing increasing doses up to 0.3 mg/kg APX005M + nivolumab.
Measured: Up to 21 days following first dose of APX005M and nivolumab
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group
ORR defined as the rate of patients who show as best overall response; either a complete response (CR) or a partial response (PR). The ORR can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. using computed tomography (CT) scans/magnetic resonance imaging (MRI). Per RECIST v1.1, for target lesions and assessed by imaging: Complete Response, (CR), Disappearance of all target lesions and nontarget (NT) lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions and no PD in NT lesions or new lesions; Objective Response Rate (ORR)=CR + PR.
Measured: From start of the treatment (Day 1) until disease progression, withdrawal of consent, death, initiation of any anticancer therapy, lost to follow-up, or termination by the Sponsor, whichever comes first (for Phase 2: maximum up to 27 months)
Secondary outcomes (4)
Safety of the APX005M and Nivolumab Combination (Phase 2)
Number of participants with TEAEs are reported.
Measured: Day 1 up to 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) following the after the last dose of APX005M and/or nivolumab (from start of treatment up to 27 months)
Duration of Response (DOR) as Per RECIST 1.1(Phase 2)
Duration of Response is defined as the time from the first evidence of confirmed partial response (PR) or better by Per RECIST v1.1 to disease progression or death due to any cause; in subjects alive without progressive disease (PD), DOR was censored on the date of the last tumor assessment. PD is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Maximum up to 25 months
Median Progression-free Survival (PFS) (Phase 2)
Progression-free Survival (PFS) in each cohort, measured from first dose to the earlier of PD (by RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: From start of treatment (Day 1) up to 27 months
6-month PFS Rate (Phase 2)
PFS rate in each cohort, measured from first dose to the earlier of PD (by RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: * Outcome Measure Time Frame From start of treatment (Day 1) to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start10 Jul 2017
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies 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
- Model description
- Phase 1b dose escalation with up to 4 sequential dose levels. Followed by Phase 2 dose expansion at Recommended Phase 2 Dose in 3 parallel disease cohorts.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apexigen America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Pyxis Oncology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123783
- Sponsor's protocol ID
- APX005M-002
- Status last verified
- Dec 2023
- First submitted
- 17 Apr 2017
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT03123783
- Acronym / sponsor ID
- APX005M-002
- Conditions
- Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma, Neoplasm of Lung, Melanoma
- Keywords
- CD40, Immunotherapy, Nivolumab, APX005M, PD-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Apexigen America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Detailed description
APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase 1) followed by a Phase 2 tumor specific portion.
Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death, whichever occurs first.
Study objectives include:
- Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab
- Evaluate safety of the APX005M and nivolumab combination
- Evaluate the objective response rate, duration of response and median PFS by RECIST 1.1 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab
- Determine the PK of APX005M
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase 1b dose escalation with up to 4 sequential dose levels. Followed by Phase 2 dose expansion at Recommended Phase 2 Dose in 3 parallel disease cohorts.
| Arm | Type | Receives |
|---|---|---|
| Phase 1b escalation 0.03 mg/kg | Experimental | Drug: APX005M, Drug: NivolumabNon-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.03 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 1b escalation 0.1 mg/kg | Experimental | Drug: APX005M, Drug: NivolumabNon-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.1 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 1b escalation 0.3 mg/kg | Experimental | Drug: APX005M, Drug: NivolumabNon-small cell lung cancer (NSCLC) or metastatic melanoma APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 1 | Experimental | Drug: APX005M, Drug: NivolumabImmunotherapy naïve, metastatic or locally advanced NSCLC APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 2 | Experimental | Drug: APX005M, Drug: NivolumabMetastatic melanoma progressing during treatment with anti-PD-1/PD-L1 therapy APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
| Phase 2 expansion Cohort 3 | Experimental | Drug: APX005M, Drug: NivolumabMetastatic or locally advanced NSCLC progressing during treatment with anti-PD-1/PD-L1: * Group A: best response of progressive disease or with stable disease < 16 weeks * Group B: tumor response or with stable disease ≥ 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1 pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naive or could have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the appropriate therapy and progressed
- Histologically or cytologically confirmed unresectable or metastatic melanoma that progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD>=4 weeks later. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
- Measurable disease by RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (8 listed)
- Previous exposure to any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1, anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of patients that must have previous treatment with anti-PD-1/PD-L1 therapy
- Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured
- Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
- Use of systemic corticosteroids or other systemic immunosuppressive drugs
- Active, known or suspected autoimmune disease
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 |
|---|---|---|
| APX005MAPX005M is a CD40 agonistic monoclonal antibody | Drug | Phase 1b escalation 0.03 mg/kg, Phase 1b escalation 0.1 mg/kg, Phase 1b escalation 0.3 mg/kg, Phase 2 expansion Cohort 1, Phase 2 expansion Cohort 2, Phase 2 expansion Cohort 3 |
| NivolumabAlso: OpdivoNivolumab is an immune checkpoint (PD-1) blocking antibody | Drug | Phase 1b escalation 0.03 mg/kg, Phase 1b escalation 0.1 mg/kg, Phase 1b escalation 0.3 mg/kg, Phase 2 expansion Cohort 1, Phase 2 expansion Cohort 2, Phase 2 expansion Cohort 3 |
Primary outcome
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: Up to 21 days following first dose of APX005M and nivolumab
All toxicities were graded according to the NCI-CTCAE version 4.03. DLT was defined as any of the following events attributed to APX005M and nivolumab combination: * Grade 4 hematologic toxicity lasting ≥ 7 days (except asymptomatic lymphopenia) * Grade 3 or 4 neutropenia with a single temperature of >38.3◦ C (101◦ F) or a sustained temperature of ≥38◦ C (100.4◦ F) for more than one hour * Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia with signs or symptoms of bleeding or requiring platelet transfusion * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity lasting >3 days despite optimal supportive care * Any Grade ≥ 3 non-hematologic laboratory value if: medical intervention is required to treat the subject, abnormality leads to hospitalization, or abnormality persists for >1 week * Failure to recover from a treatment-related AE to baseline or ≤ Grade 1 within 12 weeks of last dose of investigational product * Grade 5 toxicity.
Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b)
Time frame: Up to 21 days following first dose of APX005M and nivolumab
Establish the MTD dose of APX005M combined with 360 mg of nivolumab for which for which < 33% of DLT- evaluable participants experience a DLT. In Phase 1b, the RP2D was based on the overall safety and tolerability of the combination of APX005M and nivolumab by testing increasing doses up to 0.3 mg/kg APX005M + nivolumab.
Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group
Time frame: From start of the treatment (Day 1) until disease progression, withdrawal of consent, death, initiation of any anticancer therapy, lost to follow-up, or termination by the Sponsor, whichever comes first (for Phase 2: maximum up to 27 months)
ORR defined as the rate of patients who show as best overall response; either a complete response (CR) or a partial response (PR). The ORR can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. using computed tomography (CT) scans/magnetic resonance imaging (MRI). Per RECIST v1.1, for target lesions and assessed by imaging: Complete Response, (CR), Disappearance of all target lesions and nontarget (NT) lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions and no PD in NT lesions or new lesions; Objective Response Rate (ORR)=CR + PR.
4 secondary outcomes
Safety of the APX005M and Nivolumab Combination (Phase 2)
Time frame: Day 1 up to 30 days (or 100 days for SAEs and AEs with potential immunologic etiology) following the after the last dose of APX005M and/or nivolumab (from start of treatment up to 27 months)
Duration of Response (DOR) as Per RECIST 1.1(Phase 2)
Time frame: Maximum up to 25 months
Median Progression-free Survival (PFS) (Phase 2)
Time frame: From start of treatment (Day 1) up to 27 months
6-month PFS Rate (Phase 2)
Time frame: * Outcome Measure Time Frame From start of treatment (Day 1) to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Medical Director study director
Pyxis Oncology, Inc
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APX005M and Nivolumab in people with Cancer and Non Small Cell Lung Cancer Metastatic, run by Apexigen America, Inc. at 23 sites in 2 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Spain. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) (time frame: Up to 21 days following first dose of APX005M and nivolumab). The study lists 3 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 26 Dec 2023.