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Monoclonal Antibodies

KY1044 + Atezolizumab for Advanced Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Kymab Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years (≥20 years in Taiwan)
Histologically documented advanced/metastatic malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, KY1044, to see if it is safe and effective for treating advanced cancer in patients who have no other treatment options.

Who is the study for?
Adults over 18 with advanced cancers like lung, breast, kidney, liver, and others who have no remaining standard treatment options or for whom a clinical trial is suitable. They must be able to undergo a tumor biopsy and have an acceptable performance status.Check my eligibility
What is being tested?
The study tests KY1044 alone and combined with Atezolizumab in patients with various advanced cancers. It's designed to assess the safety and effectiveness of these treatments when standard therapies fail.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms, fatigue, changes in blood counts which could increase infection risk. Specific side effect profiles will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old, or 20 if living in Taiwan.
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My cancer has spread and this was confirmed by a lab test.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of DLTs with KY1044 in combination with atezolizumab (Phase 1)
Incidence of Dose Limiting Toxicities (DLTs) with KY1044 as single agent (Phase 1)
Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)
+2 more
Secondary outcome measures
Best overall response (BOR) per RECIST 1.1
Duration of Response (DOR) per RECIST 1.1
Half-life (t1/2) of of KY1044 and of atezolizumab if in combination
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: KY1044 monotherapy phase 2Experimental Treatment1 Intervention
KY1044 monotherapy
Group II: KY1044 monotherapy phase 1Experimental Treatment1 Intervention
KY1044 monotherapy dose escalation
Group III: KY1044 and atezolizumab phase 2Experimental Treatment1 Intervention
KY1044 and atezolizumab combination
Group IV: KY1044 and atezolizumab phase 1Experimental Treatment1 Intervention
KY1044 and atezolizumab combination dose escalation

Find a Location

Who is running the clinical trial?

Kymab LimitedLead Sponsor
4 Previous Clinical Trials
567 Total Patients Enrolled
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,200 Total Patients Enrolled
Kymab Responsible Medical OfficerStudy DirectorKymab Ltd

Media Library

Oral Squamous Cell Carcinoma Research Study Groups: KY1044 monotherapy phase 1, KY1044 and atezolizumab phase 1, KY1044 monotherapy phase 2, KY1044 and atezolizumab phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial represent an unprecedented endeavor?

"At present, the combination of KY1044 and atezolizumab is being studied in more than 350 trials across 74 nations. It was initially researched by Hoffmann-La Roche back in 2008; this investigation recruited 720 subjects and completed its Phase 2 evaluation successfully. Subsequently, 80 further analyses have been finalized since then."

Answered by AI

How many participants have been recruited for this trial thus far?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is in active search for participants and was first announced on January 28th 2019 with its most recent update occurring November 3rd 2022. The trial requires 280 individuals from three different sites."

Answered by AI

In what contexts do KY1044 and atezolizumab offer therapeutic benefit?

"The combination of KY1044 and atezolizumab is frequently prescribed to treat small-cell lung cancer, but can also be utilized in other cases such as malignant neoplasms, non-small cell lung carcinoma, and postoperative."

Answered by AI

Is there still capacity for enrollment in this clinical research endeavor?

"Affirmative. The data hosted on clinicaltrials.gov attests that this medical investigation, which was first posted on January 28th 2019, is actively searching for participants. Approximately 280 individuals need to be enrolled from 3 different healthcare facilities."

Answered by AI

Have any prior experiments combined KY1044 and atezolizumab?

"In 2008, KY1044 and atezolizumab were first studied together at SCRI Tennessee Oncology Chattanooga. Since then 80 trials have been concluded while an additional 351 are underway across the world, with a notable concentration of studies occurring in Orlando, Florida."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer
2019. "Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03829501.
~45 spots leftby Apr 2025
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