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ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration.

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration.

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013

Per Norlén, MD, PhD

Dorte Nielsen, MD, PhD

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.

ADC-1013 First-in-Human Study

A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013

Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.

Alligator Bioscience AB

The starting dose is 0.03 mg/kg every 3 weeks (q3w) and up to 6 dose levels are planned.

Study treatment will be administered as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first.

The starting dose is 0,5 mg/kg every week (q1w) and up to 3 dose levels are planned.

Study treatment will be administered as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first.

The study will start with dose-escalation cohorts to determine the recommended dose for expansion (RDE) or the maximum tolerated dose (MTD).

Once the RDE (or MTD) has been determined, a safety expansion cohort will be opened and additional patients will be treated with MP0317 monotherapy at this dose to confirm safety in a larger population.

Study treatment will be administered every 3 weeks (q3w) as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first. Treatment beyond PD will be allowed as per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST).

MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q3w regimen)

The study will start with dose-escalation cohorts to determine the recommended dose for expansion (RDE) or the maximum tolerated dose (MTD).

Once the RDE (or MTD) has been determined, a safety expansion cohort will be opened and additional patients will be treated with MP0317 monotherapy at this dose to confirm safety in a larger population.

Study treatment will be administered every week (q1w) as an intravenous (IV) infusion until progressive disease (PD), unacceptable toxicity, withdrawal of consent or other reasons to discontinue treatment occur, whichever comes first. Treatment beyond PD will be allowed as per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST).

MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q1w regimen)

This study is investigating a new experimental therapy, MP0317, a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40. Preclinical studies suggest that MP0317 may provide benefit for the treatment of tumors known to express high levels of FAP and for which approved therapies have been exhausted. This is the first study of MP0317 in humans and its main purpose is to test its safety and tolerability in patients with advanced solid tumors. This study will also examine the blood levels of MP0317 at several increasing dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity.

First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

A Phase 1, First-in-human, Multicenter, Open-label, Dose-escalation Study to Characterize the Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

DLTs will be reviewed as a subset of AEs that occur within 4 weeks after first study drug administration

Based on occurrence of DLTs within an adaptive study design following Bayesian Logistic Regression Model (BLRM)

Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and SAEs

Including parameters like maximum serum concentration (Cmax), time at Cmax (Tmax), minimal serum concentration (Cmin)

Proportion of participants with complete response (CR) and partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Best overall response (BOR) of CR, PR or stable disease (SD) lasting 4 or more weeks following first study drug administration

For participants with CR or PR, DOR will be calculated as the time from CR or PR to progressive disease (PD) or death.

Time from first study drug administration to PD

Time from first study drug administration to PD or death

Time from first study drug administration to death of any cause

Molecular Partners AG

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SEA-CD40 (administered IV) + pembrolizumab

SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel

Given intravenously; schedule is cohort-specific.

Intravenous (IV) SEA-CD40

Given subcutaneously on Day 1 every 3 weeks

Subcutaneous (SC) SEA-CD40

1000 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle

125 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle

Nab-paclitaxel

Michael Schmitt, MD, PhD

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

The study will be conducted in the following parts:

Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.

Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A.

Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.

Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part C.

Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors.

Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E.

Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors.

Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G.

(Note: There is no Part I)

Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas.

Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part J.

Part L: Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD and/or OBD. An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used.

In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or OBD cannot be identified. Parts B, D, F, H, K. and L will explore the recommended dosing regimen once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ADC-1013 First-in-Human Study	NCT02379741	Neoplasms Solid Tumors	ADC-1013	18 Years -	Alligator Bioscience AB
First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors	NCT05098405	Advanced Malign...	MP0317, a tri-s... MP0317, a tri-s...	18 Years -	Molecular Partners AG
Safety Study of SEA-CD40 in Cancer Patients	NCT02376699	Carcinoma, Non-... Carcinoma, Squa... Hodgkin Disease Lymphoma Lymphoma, B-Cel... Lymphoma, Folli... Lymphoma, Large... Melanoma Neoplasm Metast... Neoplasms, Head... Neoplasms, Squa... Non-Small Cell ... Non-Small Cell ... Non-small Cell ... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell N... Lymphoma, Non-H... Pancreatic Aden...	Intravenous (IV... Pembrolizumab Subcutaneous (S... Gemcitabine Nab-paclitaxel	18 Years -	Seagen Inc.
Safety Study of SEA-CD40 in Cancer Patients	NCT02376699	Carcinoma, Non-... Carcinoma, Squa... Hodgkin Disease Lymphoma Lymphoma, B-Cel... Lymphoma, Folli... Lymphoma, Large... Melanoma Neoplasm Metast... Neoplasms, Head... Neoplasms, Squa... Non-Small Cell ... Non-Small Cell ... Non-small Cell ... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell N... Lymphoma, Non-H... Pancreatic Aden...	Intravenous (IV... Pembrolizumab Subcutaneous (S... Gemcitabine Nab-paclitaxel	18 Years -	Seagen Inc.
First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors	NCT05098405	Advanced Malign...	MP0317, a tri-s... MP0317, a tri-s...	18 Years -	Molecular Partners AG

Spots Global Cancer Trial Database for cd40 antigen

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