Trial · NCT03123783
CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
NCT03123783, Phase 1, Phase 2, Completed, Apexigen America, Inc.; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab. Trials, record NCT03123783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03123783
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
- NCT number
- NCT03123783
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Apexigen America, Inc.
- Conditions
- Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma, Neoplasm of Lung, Melanoma
- Interventions
- APX005M, Nivolumab
- First posted
- 2017-04-21
- Last updated
- 2023-12-26
- Results first posted
- 2023-12-05
- Limitations and caveats
- In the AE section, DL3 participant data had no DLTs; AE data collected from DL3 was also added to Phase 2.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | 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. |
| Primary | Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b) | 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. |
| Primary | Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | 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. |
| Secondary | Safety of the APX005M and Nivolumab Combination (Phase 2) | 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) | Number of participants with TEAEs are reported. |
| Secondary | Duration of Response (DOR) as Per RECIST 1.1(Phase 2) | Maximum up to 25 months | 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. |
| Secondary | Median Progression-free Survival (PFS) (Phase 2) | From start of treatment (Day 1) up to 27 months | 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. |
| Secondary | 6-month PFS Rate (Phase 2) | * Outcome Measure Time Frame From start of treatment (Day 1) to 6 months | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to 21 days following first dose of APX005M and nivolumab | All participants in the safety population who received at least 1 dose of study drug in the escalation cohorts (APX005M 0.03 mg/kg + nivolumab; APX005M 0.1 mg/kg + nivolumab; APX005M 0.3 mg/kg + nivolumab) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b) | Up to 21 days following first dose of APX005M and nivolumab | All participants in the safety population who received at least 1 dose of study drug in the escalation cohorts (APX005M 0.03 mg/kg + nivolumab; APX005M 0.1 mg/kg + nivolumab; APX005M 0.3 mg/kg + nivolumab) | mg/kg | NUMBER |
| PRIMARY | Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | 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) | Cohort 1: immunotherapy naïve metastatic or locally advanced NSCLC, Cohort 2: unresectable or metastatic melanoma that progressed during treatment with anti-PD-1/PD-L1 therapy and had confirmation of PD ≥4 weeks, Cohort 3: PD1-NSCLC metastatic or locally advanced NSCLC not amenable to curative treatment that progressed during prior treatment with anti-PD-1/PD-L1 therapy. Cohort 3A: best response of PD or with SD \<16 weeks, Cohort 3B includes PD1-NSCLC with tumor response or with SD ≥ 16 weeks | Percentage of participants | NUMBER |
| SECONDARY | Safety of the APX005M and Nivolumab Combination (Phase 2) | 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) | Any Adverse Event a participant has with two or more events in that category is counted only once | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) as Per RECIST 1.1(Phase 2) | Maximum up to 25 months | Cohort 1: immunotherapy naïve metastatic or locally advanced NSCLC, Cohort 2: unresectable or metastatic melanoma that progressed during treatment with anti-PD-1/PD-L1 therapy and had confirmation of PD ≥4 week. Cohort 3A/PD1-NSCLC and Cohort 3B/PD1 NSCLC had no objective response and therefore DOR could not be assessed. | Months | MEDIAN |
| SECONDARY | Median Progression-free Survival (PFS) (Phase 2) | From start of treatment (Day 1) up to 27 months | Cohort 1: immunotherapy naïve metastatic or locally advanced NSCLC, Cohort 2: unresectable or metastatic melanoma that progressed during treatment with anti-PD-1/PD-L1 therapy and had confirmation of PD ≥4 weeks, Cohort 3: PD1-NSCLC metastatic or locally advanced NSCLC not amenable to curative treatment that progressed during prior treatment with anti-PD-1/PD-L1 therapy. Cohort 3A: best response of PD or with SD \<16 weeks, Cohort 3B includes PD1-NSCLC with tumor response or with SD ≥ 16 weeks. | Months | MEDIAN |
| SECONDARY | 6-month PFS Rate (Phase 2) | * Outcome Measure Time Frame From start of treatment (Day 1) to 6 months | Cohort 1: immunotherapy naïve metastatic or locally advanced NSCLC, Cohort 2: unresectable or metastatic melanoma that progressed during treatment with anti-PD-1/PD-L1 therapy and had confirmation of PD ≥4 weeks, Cohort 3: PD1-NSCLC metastatic or locally advanced NSCLC not amenable to curative treatment that progressed during prior treatment with anti-PD-1/PD-L1 therapy. Cohort 3A: best response of PD or with SD \<16 weeks, Cohort 3B includes PD1-NSCLC with tumor response or with SD ≥ 16 weeks. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Phase 1b Escalation | 0 | Participants | ||
| Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b) | Phase 1b Escalation | NA | mg/kg | ||
| Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | Cohort 1 (Arm)/inNSCLC (Phase 2) | 16.67 | 90% Confidence Interval 8.57 to 28.07 | Percentage of participants | |
| Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | Cohort 2(Arm)/PD1-MM (Phase 2) | 15.15 | 90% Confidence Interval 6.17 to 29.25 | Percentage of participants | |
| Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | Cohort 3A(Arm)/PD1-NSCLC (Phase 2) | 0.00 | 90% Confidence Interval 0.00 to 22.09 | Percentage of participants | |
| Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group | Cohort 3B(Arm)/PD1-NSCLC (Phase 2) | 0.00 | 90% Confidence Interval 0.00 to 11.29 | Percentage of participants | |
| Safety of the APX005M and Nivolumab Combination (Phase 2) | Cohort 1 (Arm)/inNSCLC (Phase 2) | 52 | Participants | ||
| Safety of the APX005M and Nivolumab Combination (Phase 2) | Cohort 2(Arm)/PD1-MM (Phase 2) | 36 | Participants | ||
| Safety of the APX005M and Nivolumab Combination (Phase 2) | Cohort 3A(Arm)/PD1-NSCLC (Phase 2) | 14 | Participants | ||
| Safety of the APX005M and Nivolumab Combination (Phase 2) | Cohort 3B(Arm)/PD1-NSCLC (Phase 2) | 28 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow70
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b | STARTED | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b) | 3 | |
| Phase 1b | STARTED | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b) | 4 | |
| Phase 1b | STARTED | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b) | 3 | |
| Phase 1b | STARTED | Cohort 1(Arm)/ inNSCLC (Phase 2) | 0 | |
| Phase 1b | STARTED | Cohort 2(Arm)/ PD1-MM (Phase 2) - | 0 | |
| Phase 1b | STARTED | Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) | 0 | |
| Phase 1b | STARTED | Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) | 0 | |
| Phase 1b | Participants in the Safety Population | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b) | 3 | |
| Phase 1b | Participants in the Safety Population | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b) | 3 | |
| Phase 1b | Participants in the Safety Population | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b) | 3 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 participant flowAdverse events1,491
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3 | 13 | 53 | 31 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3 | 4 | 38 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) | 0 | 14 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) | 6 | 28 | 10 |
| other | Palpitations | Cardiac disorders | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 | 0 |
1 to 10 of 1,491Source ClinicalTrials.gov
See all 1,491 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) | 1 | 3 |
| Total, all-cause mortality | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) | 1 | 3 |
| Total, all-cause mortality | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) | 0 | 3 |
| Total, all-cause mortality | Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3 | 18 | 53 |
| Total, all-cause mortality | Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3 | 4 | 38 |
| Total, all-cause mortality | Cohort 3A(Arm)/ PD1-NSCLC (Phase 2) | 4 | 14 |
| Total, all-cause mortality | Cohort 3B(Arm)/ PD1-NSCLC (Phase 2) | 9 | 28 |
| Total, other adverse events | DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation) | 3 | 3 |
| Total, other adverse events | DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation) | 3 | 3 |
| Total, other adverse events | DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation) | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03123783
GET https://conductscience.org/api/trials/v1/NCT03123783/flow?page=2