First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

  • STATUS
    Recruiting
  • End date
    Sep 7, 2023
  • participants needed
    123
  • sponsor
    AstraZeneca
Updated on 5 May 2021
ct scan
cancer
monoclonal antibodies
breast cancer
lung cancer
progressive disease
medi4736
durvalumab
solid tumour
triple negative breast cancer
squamous cell carcinoma of head and neck
lung carcinoma
small lung

Summary

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

Description

This is a Phase I, First in Human, multicentre, open-label, multiple arm study with dose escalations and expansions at selected doses. Dose-escalation will occur with AZD8701 in monotherapy (Part 1) and in combination with durvalumab (Part 3) in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastric cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment.

Disease specific expansions will occur with a selected dose AZD8701 in participants with NSCLC (Part 2) and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC (Part 4).

Details
Condition Non-Small Cell Lung Cancer, Cervical Cancer, Disorders of cervix NOS, Uterine Cancer, Breast Cancer, melanoma, skin cancer, Small Cell Lung Cancer, Gastropathy, Gastric Cancer, Diet and Nutrition, Chronic Diarrhea, Stomach Discomfort, Skin Wounds, Metastatic Melanoma, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Advanced Solid Tumours, Triple Negative Breast Neoplasms, Gastric Carcinoma, Recurrent Respiratory Papillomatosis, Squamous Cell Cancer of Head and Neck, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Malignant Melanoma, Stomach Cancer, Clear Cell Renal Cell Cancer, cervical carcinoma, gastric cancers, nsclc, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment durvalumab, AZD8701
Clinical Study IdentifierNCT04504669
SponsorAstraZeneca
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 101 yrs?
Gender: Male or Female
Do you have any of these conditions: or Recurrent Respiratory Papillomatosis or Metastatic Melanoma or Injection Port or Triple Negative Breast Neoplasms or Small Cell Lung Cancer or Sto...?
Do you have any of these conditions: or Chronic Diarrhea or carcinoma of cervix or Peripheral Arterial Occlusive Disease or skin cancer or cervix cancer or sclc or Stomach Discomfort or ...?
Do you have any of these conditions: or Brain Function or Disorders of cervix NOS or Stomach Cancer or Pediatric Health or Triple Negative Breast Cancer or gastric cancers or Chronic Dia...?
Do you have any of these conditions: or Clear Cell Renal Cell Cancer or cervical cancer, uterine or Adverse Effects, Drugs or sclc or Squamous Cell Cancer of Head and Neck or Chronic Sho...?
Do you have any of these conditions: or Razor Bumps (Pseudofolliculitis Barbae) or carcinoma of the cervix uteri or Advanced Solid Tumours or Primary Immunodeficiency or Peripheral Arter...?
Do you have any of these conditions: or Stomach Cancer or gastric cancers or Uterine Cancer or Razor Bumps (Pseudofolliculitis Barbae) or Triple Negative Breast Cancer or Vaginal Atrophy...?
Do you have any of these conditions: or melanoma or Non-Small Cell Lung Cancer or Pediatric Health or Injection Port or Small Cell Lung Cancer or Primary Immunodeficiency or Metastatic M...?
Do you have any of these conditions: Non-Small Cell Lung Cancer or cervical carcinoma or Skin Wounds or Triple Negative Breast Neoplasms or Pediatric Health or carcinoma of cervix or canc...?
Do you have any of these conditions: Injection Port or cancer of the cervix or sclc or skin cancer or Metastatic Melanoma or Gastropathy or small cell carcinoma or cervical cancer, uterin...?
Do you have any of these conditions: Breast Cancer or Stomach Cancer or Gastric Carcinoma or melanoma or Non-Small Cell Lung Cancer or Uterine Cancer or Vaginal Atrophy or Primary Immunod...?
Do you have any of these conditions: Small Cell Lung Cancer or melanoma or Gastric Cancer or Adverse Effects, Drugs or Chronic Shoulder Pain or Breast Cancer - HER2 Positive or cervical c...?
Do you have any of these conditions: Gastric Carcinoma or Non-Small Cell Lung Cancer or Gastropathy or Advanced Solid Tumours or Injection Port or Uterine Cancer or carcinoma of cervix or...?
The study is comprised of 2 main parts Monotherapy (AZD8701) and Combined
Therapy (AZD8701 and Durvalumab)
Inclusion criteria Dose escalation stages
Histological or cytological confirmation of a solid, malignant tumour including HNSCC, TNBC, NSCLC, ccRCC, gastric cancer, melanoma, cervical cancer, SCLC, and/or participants with other solid tumours who have demonstrated a response to prior anti-PD-(L)1 treatment
Participant with progressive disease that is refractory to standard therapies or for which no standard therapies exist and a clinical trial is the best option for next treatment based on prior response and/or tolerability to standard of care
Inclusion Criteria Dose Expansions
Non Small Lung Cancer Participants who have received prior PD(L)1 treatment
Clear Cell Renal Cancer Participants who have not received prior PD(L)1
treatment
Triple negative Breast Cancer participants who have who have not received
prior PD(L)1 treatment
General inclusion criteria
Must be 18 year old at the time of screening
Body weight > 35 kg
Male and Female participants of childbearing potential must use effective methods of contraception
Capable of giving signed informed consent
ECOG performance status of 0 to 1
A serum albumin > 35g/L
Life expectancy of > 12 weeks
At least 1 lesion, that qualifies as a RECIST 1.1 target lesion at baseline. Tumour assessment by CT scan or MRI must be performed within 28 days prior to treatment
Participants must provide a new or previous tumour sample
Adequate organ system functions

Exclusion Criteria

A condition that, in the opinion of the Investigator, would interfere with evaluation of the study intervention or interpretation of participant safety or study results
History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness
Significant cardiac disease
History of another primary malignancy except for
Malignancy treated with curative intent and with no known active disease 5 years
non-melanoma skin cancer
Adequately treated carcinoma in situ without evidence of disease
Any major unresolved toxicity from previous anticancer therapy
Participant with previous or confirmed Covid 19 diagnosis requiring significant medical intervention
Current clinical signs and symptoms consistent with COVID-19 or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to screening
Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients
Prior/Concomitant Therapy
Receipt of the last dose of anticancer therapy within 5 half-lives or 21 days prior to the first dose of study
Prior treatment with potential Treg depletion therapies including agents targeting CTLA-4 for 90 days prior to enrolment on study
Participants who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline
Must not have experienced a Grade 3 imAE or a neurologic or ocular imAE of any grade while receiving prior immunotherapy
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. b. The following are exceptions to this criterion
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study intervention
Major surgical procedure within 28 days prior to the first dose
Participants receiving anticoagulation treatment for venous or arterial indications
Participation in another clinical study with study intervention administered in the last 30 days
Female participants who are pregnant or breastfeeding or male and female participants of reproductive potential who are not willing to employ effective birth control
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