KY1044 and atezolizumab for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Kymab investigational site 3901, Milano, Italy
Oral Squamous Cell Carcinoma+15 More
KY1044 and atezolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

This study is evaluating whether a drug may help treat cancer.

See full description

Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
  • Triple Negative Breast Neoplasms
  • Carcinoma
  • Melanoma
  • Cervical Cancers
  • Esophageal Neoplasms Malignant
  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Malignant Neoplasm of Pancreas
  • Renal Cell Adenocarcinoma
  • Cancer, Advanced
  • Metastatic Cancers
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether KY1044 and atezolizumab will improve 7 primary outcomes and 13 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Within first 21 days of treatment.

Month 24
Survival rate
Up to 48 months
Best overall response (BOR) per RECIST 1.1
Half-life (t1/2) of of KY1044 and of atezolizumab if in combination
Maximum Concentration (Cmax) of KY1044 and of atezolizumab if in combination
Number of dose interruptions, reductions and dose intensity (Phase 2)
Number of participants with anti-KY1044 and anti-atezolizumab antibodies
Number of participants with presence of tumor-infiltrating lymphocytes (TILs) as determined by expression of ICOS (Inducible T cell Costimulator), FOXP3 (Forkhead box P3) and CD8 cells
ORR per Immune-Related Response Evaluation Criteria in Solid Tumors (iRECIST) (Phase 1 and Phase 2)
ORR per RECIST 1.1 (Phase 1)
Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)
PFS per iRECIST (Phase 1 and Phase 2)
Safety: Incidence and severity of AEs and SAEs (Phase 2)
Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1)
Tolerability: Number of dose interruptions, reductions and dose intensity (Phase 1)
Month 3
Duration of Response (DOR) per RECIST 1.1
Progression Free Survival (PFS) per RECIST 1.1
Day 21
Incidence of DLTs with KY1044 in combination with atezolizumab
Incidence of DLTs with KY1044 in combination with atezolizumab (Phase 1)
Incidence of Dose Limiting Toxicities (DLTs) with KY1044 as single agent
Incidence of Dose Limiting Toxicities (DLTs) with KY1044 as single agent (Phase 1)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
KY1044 and atezolizumab phase 1

This trial requires 412 total participants across 4 different treatment groups

This trial involves 4 different treatments. KY1044 And Atezolizumab is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

KY1044 and atezolizumab phase 1
Drug
KY1044 and atezolizumab combination dose escalation
KY1044 and atezolizumab phase 2
Drug
KY1044 and atezolizumab combination
KY1044 monotherapy phase 1
Drug
KY1044 monotherapy dose escalation
KY1044 monotherapy phase 2
Drug
KY1044 monotherapy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 12 and 24 months for reporting.

Closest Location

Kymab investigational site 1103 - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 15 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cervical (anti-PD-(L)1 therapy naïve and pre-treated)
Indications, in which signs of anti-tumor activity has been observed in Phase 1 with KY1044 in combination with atezolizumab
Age ≥18 years (≥20 years in Taiwan)
Histologically documented advanced/metastatic malignancies
Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer)
Phase 2 KY1044 single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of KY1044 as single agent
NSCLC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
Gastric (anti-PD-(L)1 therapy naïve and pre-treated)
Recurrent and/or metastatic HNSCC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
You have not received PD-L1 therapy before. show original

Patient Q&A Section

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

How many people get oral squamous cell carcinoma a year in the United States?

Add answer

Around 75,000 new cases of oral squamous cell carcinoma are diagnosed per year in the United States, making it the fifth most important cancer in American men. The occurrence of oral cancer is strongly modulated by tobacco use; it is more frequent in heavy smokers.

Unverified Answer

What are common treatments for oral squamous cell carcinoma?

Add answer

This article will discuss the current therapies used in the treatment of oral squamous cell carcinoma in adults. Surgically invasive methods are not typically needed or favored due to lack of proven efficacy or the adverse effects associated with such procedures, though several techniques are still used. Treatment modalities for tongue SCC are largely limited to radiotherapy and chemotherapies, as traditional surgical methods have been replaced by laser diathermy and digital excision in recent times. Surgical treatment continues to be used in the treatment of more advanced lesions. The most common treatment modality for oral cavity SCC is radiation therapy that usually involves the postero-oral region.

Unverified Answer

What are the signs of oral squamous cell carcinoma?

Add answer

The most frequently involved site of oral squamous cell carcinoma is the gingiva. The risk factors associated with an increased risk of oral squamous cell carcinoma include smoking and betel nut use. The onset of gingival overgrowth is also an early sign of oral squamous cell carcinoma. The risk of oral squamous cell carcinoma increases as the gingival indices increase. Mucositis is a

Unverified Answer

Can oral squamous cell carcinoma be cured?

Add answer

The OSCC can't be cured and is fatal in about 50% with proper treatment (radical resection). However, the treatment is often quite successful (over 90% in the literature); hence, the long survival seen (over 80%) in the literature is not unusual.

Unverified Answer

What is oral squamous cell carcinoma?

Add answer

Oral squamous cell carcinoma is the most common tumour in the pharynx and constitutes around 20% of all oral and oropharyngeal cancer cases. Treatment is usually multimodal; oral surgery is often the initial treatment in an attempt to control the tumour in the tongue or naso-facial region. Radiation therapy can be used if there is local recurrence prior to reconstruction in patients with a good performance status and a complete surgical resection. Radiation therapy is not usually recommended in patients undergoing reconstruction after cancer resection.

Unverified Answer

What causes oral squamous cell carcinoma?

Add answer

The risk factors of OSCC are different from those of oral benign lesions. The high frequency of tobacco use is most often the main cause for oral ESCC. The incidence is decreasing, and it is more likely to be encountered in the second half of the twentieth century.

Unverified Answer

Have there been other clinical trials involving ky1044 and atezolizumab?

Add answer

No studies have been done so far comparing ky1044 with atezolizumab. Although most patients enrolled in atezolizumab studies were treated with chemotherapy, this does not necessarily exclude those treated with ky1044. In addition, the inclusion and exclusion criteria may differ greatly among clinical trials, such as the timing of the treatment. In some of the studies evaluated, ky1044 might be better tolerated than other drugs. These clinical trials are not the final word on ky1044 but should be considered before deciding on this drug as a first-line treatment for NSCLC.

Unverified Answer

Have there been any new discoveries for treating oral squamous cell carcinoma?

Add answer

Oral cancers that are currently diagnosed tend to be invasive and more likely to recur than superficial cancers. The recurrence in oral cancers is usually a result of a poorly-designed treatment plan; therefore, it is important to select the proper treatment at the time of diagnosis. There are a number of studies examining oral carcinoma treatments via case reports and small studies. Few oral surgical treatments have been described in the literature, however, many other treatments have been in development. Oral squamous cell carcinoma, like other oral and maxillofacial cancers, can be treated with radiation, chemotherapy, and surgery; however, the prognosis is relatively poor, and as such, the treatment plan is often designed to increase survival.

Unverified Answer

What is the latest research for oral squamous cell carcinoma?

Add answer

Studies were reviewed in three main areas: biological, clinical-pathological characterization of OSCC and OSCC risk assessment. The emerging concepts for oral cancer are: The genetic components are being addressed through basic research studies (including gene-expression profiling studies), which are then translocated to clinical practice. Clinically, there are significant research efforts on identifying gene-expression patterns, on identifying biological marker proteins through immunohistochemical studies, and on determining the response to treatment options (chemotherapy and/or radiation). Further, the evolving strategies in the field of personalized medicine are aimed at understanding genetic alterations in patients and tailored therapies. These efforts are aimed at improving the quality of life of OSCC patients through the development of improved management.

Unverified Answer

Who should consider clinical trials for oral squamous cell carcinoma?

Add answer

There is no clear evidence of a survival advantage conferred by clinical trials for OSCC. It is prudent for patients to understand clinical trial procedures, costs, risks, benefits, and expected outcomes.

Unverified Answer

How serious can oral squamous cell carcinoma be?

Add answer

The survival was not different in all sites with a higher OSCC mortality in the mandible as most patients had an unfavorable stage of the disease. The survival was longer in the SCCOMG stage and in the SCCOMTG staging. The treatment of OSCC and RT in localized disease could be useful for improving the survival.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Oral Squamous Cell Carcinoma by sharing your contact details with the study coordinator.