Health TrialsbyHealthPanel

AK129 Combination Therapy for Advanced Solid Tumors

ConditionsNon-small Cell Lung Cancer Stage IIIB/IVHead and Neck Squamous Cell Carcinoma (HNSCC)Colorectal AdenocarcinomaAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);

≥18 years old and ≤ 75 years (regardless of sex);

ECOG performance status 0-1;

Life expectancy longer than 3 months;

Disqualifiers

Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;

Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene expression defect (MSI-H/dMMR)or histopathological examination confirmed other pathological types;

Participating in another clinical research;

Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK129(dose 1)

    Drug

    IV infusion

  • Pemetrexed

    Drug

    IV infusion;500mg/m2

  • Paclitaxel

    Drug

    IV infusion;175mg/m2

  • Carboplatin

    Drug

    IV infusion;AUC 5

  • AK129(dose 2)

    Drug

    IV infusion

  • Docetaxel

    Drug

    IV infusion;75mg/m2

  • Cis-platinum

    Drug

    IV infusion;100 mg/m2

  • 5-FU (5-fluorouracil)

    Drug

    IV infusion;1000 mg/m2

  • Cetuximab

    Drug

    IV infusion;400mg/m2/ 250mg/m2

  • Paclitaxel

    Drug

    IV infusion;80mg/m2

  • Docetaxel

    Drug

    IV infusion;35mg/m2

  • Chemotherapy

    Drug

    IV infusion

  • AK129(RP2D)

    Drug

    IV infusion

  • Penpulimab

    Drug

    IV infusion;200mg

Treatment groups

230 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: AK129(dose 1) + Chemotherapy(Phase Ib)Experimental treatment 4 interventions
Group B: AK129(dose 2) + Chemotherapy(Phase Ib)Experimental treatment 4 interventions
Group C: Cohort 1 PARTA Treatment Group 1(Phase II)Experimental treatment 4 interventions
Group D: Cohort 1 PARTA Treatment Group 2(Phase II)Active comparator 4 interventions
Group E: Cohort 1 PARTB(Phase II)Experimental treatment 2 interventions
Group F: Cohort 2 PARTA(Phase II)Experimental treatment 4 interventions
Group G: Cohort 2 PARTB(Phase II)Experimental treatment 4 interventions
Group H: Cohort 3(Phase II)Experimental treatment 1 intervention
Group I: Cohort 4(Phase II)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Frequency and severity of adverse events (AEs) ,Clinically significant abnormal laboratory results

Frequency and severity of AEs and clinically significant abnormal laboratory results for all arms in phase Ib/II.

Time frame
Up to approximately 2 years
2

Overall Response Rate (ORR)

ORR is the proportion of subjects with complete response(CR) or partial response(PR) for all arms in phase II , based on RECIST v1.1.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Overall Response Rate (ORR)

ORR is the proportion of subjects with complete response(CR) or partial response(PR) for all arms in phase Ib, based on RECIST v1.1.

Time frame
Up to approximately 2 years
2

Progression-Free Survival (PFS)

Evaluation of PFS based on RECIST v1.1.

Time frame
Up to approximately 2 years
3

Overall survival (OS)

Evaluation of OS based on RECIST v1.1.

Time frame
Up to approximately 2 years
4

Disease control rate (DCR)

Evaluation of DCR based on RECIST v1.1.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
Apply now